The Experts below are selected from a list of 141 Experts worldwide ranked by ideXlab platform
Maria Palmisano - One of the best experts on this subject based on the ideXlab platform.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod’s major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1–4, 0.46 mg on days 5–7, 0.92 mg on days 8–10, and 1.84 mg on days 11–30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. NCT03644576.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:INTRODUCTION The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). METHODS In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. RESULTS Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. CONCLUSION Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. TRIAL REGISTRATION NCT03644576.
Jonathan Q Tran - One of the best experts on this subject based on the ideXlab platform.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod’s major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1–4, 0.46 mg on days 5–7, 0.92 mg on days 8–10, and 1.84 mg on days 11–30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. NCT03644576.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:INTRODUCTION The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). METHODS In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. RESULTS Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. CONCLUSION Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. TRIAL REGISTRATION NCT03644576.
Peijin Zhang - One of the best experts on this subject based on the ideXlab platform.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod’s major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1–4, 0.46 mg on days 5–7, 0.92 mg on days 8–10, and 1.84 mg on days 11–30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. NCT03644576.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:INTRODUCTION The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). METHODS In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. RESULTS Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. CONCLUSION Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. TRIAL REGISTRATION NCT03644576.
Atalanta Ghosh - One of the best experts on this subject based on the ideXlab platform.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod’s major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1–4, 0.46 mg on days 5–7, 0.92 mg on days 8–10, and 1.84 mg on days 11–30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. NCT03644576.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:INTRODUCTION The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). METHODS In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. RESULTS Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. CONCLUSION Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. TRIAL REGISTRATION NCT03644576.
Mary Syto - One of the best experts on this subject based on the ideXlab platform.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod’s major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1–4, 0.46 mg on days 5–7, 0.92 mg on days 8–10, and 1.84 mg on days 11–30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. NCT03644576.
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multiple dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine a Sympathomimetic Agent in healthy subjects
Advances in Therapy, 2020Co-Authors: Jonathan Q Tran, Peijin Zhang, Susan Walker, Atalanta Ghosh, Mary Syto, Xiaomin Wang, Sarah Harris, Maria PalmisanoAbstract:INTRODUCTION The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE). METHODS In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods. RESULTS Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo. CONCLUSION Concomitant administration of ozanimod with PSE, a Sympathomimetic Agent, did not potentiate the effects on blood pressure. TRIAL REGISTRATION NCT03644576.
