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| ID | Type | Description | Link |
|---|---|---|---|
| 67896062PAH1010 | Other Identifier | Actelion | |
| 2022-000262-17 | EudraCT Number |
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The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult participants in fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Participants will receive single oral dose of macitentan formulated as dispersible final market image (FMI) in fasted conditions (test) (Treatment A) in Intervention Period 1 followed by a single oral dose of film-coated opsumit tablet in fasted conditions (reference) (Treatment B) in Intervention Period 2 on Day 1. There will be washout period of at least 10 days between two period. |
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| Treatment Sequence BA | Experimental | Participants will receive Treatment B in Intervention Period 1 followed Treatment A in Intervention Period 2 on Day 1. There will be washout period of at least 10 days between two period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan | Drug | Macitentan dispersible and film-coated tablets will be administered orally as per assigned treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Analyte Concentration (Cmax) of Macitentan | Cmax is defined as maximum observed plasma analyte concentration of macitentan. | Predose up to 216 hours postdose (up to Day 10) |
| Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero To Time of the Last Quantifiable (Non-below Quantification Limit [Non-BQL]) Concentration (AUC [0-last]) of Macitentan | AUC (0-last) is defined as area under the plasma analyte concentration versus time curve from time 0 to time of the last quantifiable (non-BQL) concentration of macitentan. | Predose up to 216 hours postdose (up to Day 10) |
| Area Under the Plasma Analyte Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Macitentan | AUC (0-infinity) is defined as the area under the plasma analyte concentration-time curve from time 0 to infinite time of macitentan, calculated as the summation of AUC(0-last) and C(last)/lambda(z); where AUC(0-last) is area under the analyte concentration-time curve from time zero to last quantifiable time, Clast is the last observed measurable (non-BQL) plasma analyte concentration, and lambda(z) is apparent terminal elimination rate constant. | Predose up to 216 hours postdose (up to Day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of Macitentan and Aprocitentan | Tmax is defined as actual sampling time to reach the maximum observed plasma analyte concentration of macitentan and aprocitentan. | Predose up to 216 hours postdose (up to Day 10) |
| Last Observed Measurable (Non-BQL) Plasma Analyte Concentration (Clast) of Macitentan and Aprocitentan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Actelion Clinical Trial | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Belgium NV | Edegem | 2650 | Belgium |
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
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| ID | Term |
|---|---|
| C533860 | macitentan |
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Clast is defined as last observed measurable (non-BQL) plasma analyte concentration of macitentan and aprocitentan. |
| Predose up to 216 hours postdose (up to Day 10) |
| Area Under the Plasma Analyte Concentration-time Curve from Time Zero to 72 Hours Postdose (AUC [0-72 Hours]) of Macitentan and Aprocitentan | AUC (0-72 hours) is defined as area under the plasma analyte concentration-time curve from time 0 to 72 hours postdose of macitentan and aprocitentan calculated by linear-linear trapezoidal summation. | Predose up to 0 to 72 hours postdose (up to Day 4) |
| Apparent Terminal Elimination Half-life (t1/2) of Macitentan and Aprocitentan | t1/2 is defined as apparent terminal elimination half-life of macitentan and aprocitentan, calculated as 0.693/lambda(z); where lambda(z) is apparent terminal elimination rate constant. | Predose up to 216 hours postdose (up to Day 10) |
| Apparent Terminal Elimination Rate Constant (Lambda[z]) of Macitentan and Aprocitentan | Lambda(z) is defined as apparent terminal elimination rate constant of macitentan and aprocitentan, estimated by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve. | Predose up to 216 hours postdose (up to Day 10) |
| Total Apparent Oral Clearance (CL/F) of Macitentan | CL/F is defined as total apparent oral clearance of macitentan, calculated as dose/AUC (0-infinity). | Predose up to 216 hours postdose (up to Day 10) |
| Apparent Volume of Distribution (Vdz/F) of Macitentan | Vdz/F of macitentan is defined as apparent volume of distribution of macitentan, calculated as dose/(Lambda[z]*AUC [0-infinity]). | Predose up to 216 hours postdose (up to Day 10) |
| Maximum Observed Plasma Analyte Concentration (Cmax) of Aprocitentan | Cmax is defined as maximum observed plasma analyte concentration of aprocitentan. | Predose up to 216 hours postdose (up to Day 10) |
| Area Under the Plasma Analyte Concentration Versus Time Curve From Time Zero To Time of the Last Quantifiable (Non-BQL) Concentration (AUC [0-last]) of Aprocitentan | AUC (0-last) is defined as area under the plasma analyte concentration versus time curve from time 0 to time of the last quantifiable (non-BQL) concentration of aprocitentan. | Predose up to 216 hours postdose (up to Day 10) |
| Area Under the Plasma Analyte Concentration-time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Aprocitentan | AUC (0-infinity) is defined as the area under the plasma analyte concentration-time curve from time 0 to infinite time of aprocitentan, calculated as the summation of AUC(0-last) and C(last)/lambda(z); where AUC(0-last) is area under the analyte concentration-time curve from time zero to last quantifiable time, Clast is the last observed measurable (non-BQL) plasma analyte concentration, and lambda(z) is apparent terminal elimination rate constant. | Predose up to 216 hours postdose (up to Day 10) |
| Number of Participants with Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. | From screening to the last follow-up visit (up to 10 weeks) |
| Number of Participants with Abnormalities in Physical Examination | Number of participants with abnormalities in physical examination (including height and body weight) will be reported. | Up to Day 10 |
| Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (including blood pressure, pulse/heart rate and oral temperature) will be reported. | Up to Day 10 |
| Number of Participants with Abnormalities in Electrocardiogram (ECG) | Number of participants with abnormalities in ECG will be reported. | Up to Day 10 |
| Number of Participants with Abnormalities in Clinical Laboratory Tests | Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry, coagulation, serology and urinalysis) will be reported. | Up to Day 10 |