A Study of Selexipag in Healthy Male Participant
A Single-center, Open-label, Randomized, Formulation Screening, Two-cohort, Four-period, Crossover Study for Selexipag Sustained Release in Healthy Male Subjects
A Single-center, Open-label, Randomized, Formulation Screening, Two-cohort, Four-period, Crossover Study for Selexipag Sustained Release in Healthy Male Subjects
Sponsor study identifier
Secondary identifiers
interventional
24
1 country
1
Study Start
January 23, 2020
Actual (reported)Primary Completion
August 14, 2020
Actual (reported)Study Completion
August 14, 2020
Actual (reported)The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679 following single oral administration of the matrix tablet and the encapsulated pellets of selexipag, each with 3 different release profiles, as compared to selexipag immediate release (IR) tablets in healthy male participants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 14, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2020
Actual (reported)February 10, 2020
Actual (reported)February 12, 2020
Actual (reported)August 14, 2020
Actual (reported)August 14, 2020
Actual (reported)Maximum Observed Analyte Concentration (Cmax) of Selexipag and ACT-333679
The Cmax is the maximum observed analyte concentration.
Predose and 0 to 72 hours postdose
Area Under Analyte Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) of Selexipag and ACT-333679
AUC (0-last) defined as the area under the analyte concentration-time curve from time zero to time of the last measurable (non-BQL) analyte concentration, calculated by linear-linear trapezoidal summation.
Predose and 0 to 72 hours postdose
Plasma analyte concentration 24 hours (C24) Post Dose of Selexipag and ACT-333679
C24 defined as plasma analyte concentration at 24 hours postdose.
Predose and 0 to 72 hours postdose
Area Under the Analyte Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
AUC (0-infinity) is defined the area under the analyte concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
Predose and 0 to 72 hours postdose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Up to 50 Days
Participants will receive oral doses of selexipag matrix tablets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period.
Participants will receive oral doses of selexipag encapsulated) pellets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period.
Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.
Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.
Clinical Pharmacology Unit
Merksem, 2170, Belgium
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
24 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2020
First Posted
February 12, 2020
Study Start
January 23, 2020
Actual (reported)A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects
Participants will receive Selexipag immediate-release tablet orally under fasted condition.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 14, 2020
Actual (reported)Study Completion
August 14, 2020
Actual (reported)Last Updated
March 30, 2025
Record last verified: 2025-03
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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