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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001258-67 | EudraCT Number | ||
| 67896062PAH1008 | Other Identifier | Actelion |
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The purpose of this study is to assess the rate and extent of absorption of macitentan following administration of a single oral dose of macitentan formulated as final market image (FMI) (test), compared to macitentan as the clinical service formulation (CSF) under fasted conditions in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Participants will receive single oral dose of macitentan formulated as final market image (FMI) in fasted conditions (test) (Treatment A) in treatment period 1 followed by a single oral dose of macitentan as the clinical service formulation (CSF) in fasted conditions (reference) (Treatment B) in treatment period 2 on Day 1. Study intervention intake in subsequent intervention periods in an individual participant will be separated by a washout period of at least 10 days. |
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| Treatment Sequence BA | Experimental | Participants will receive Treatment B in treatment period 1 followed by Treatment A in treatment period 2 on Day 1. Study intervention intake in subsequent intervention periods in an individual participant will be separated by a washout period of at least 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan | Drug | Macitentan dispersible 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 and up to 216 hours post dose (Up to Day 10) |
| Area Under the Plasma Analyte Concentration-time Curve of Macitentan from Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) | AUC (0-last) is defined as area under the plasma analyte concentration-time curve of macitentan from time zero to time of the last quantifiable (non-below quantification limit [BQL]) concentration, calculated by linear-linear trapezoidal summation. | Predose and up to 216 hours post dose (Up to Day 10) |
| Area Under the Plasma Analyte Concentration-time Curve of Macitentan from Time Zero to Infinity (AUC [0-infinity]) | AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve of macitentan from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), where AUC (0-last) is area under the plasma analyte concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) plasma analyte concentration and lambda(z) is apparent terminal elimination rate constant. | Predose and up to 216 hours post dose (Up to Day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of Macitentan and its Metabolite ACT-132577 | Tmax is defined as actual sampling time to reach the maximum observed plasma analyte concentration of macitentan and its metabolite ACT-132577. | Predose and up to 216 hours post dose (Up to Day 10) |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | 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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| Last Observed Measurable Plasma Analyte Concentration (Clast) of Macitentan and its Metabolite ACT-132577 |
Clast is defined as last observed measurable BQL plasma analyte concentration of macitentan and its metabolite ACT-132577. |
| Predose and up to 216 hours post dose (Up to Day 10) |
| Area Under the Plasma Analyte Concentration-time Curve of Macitentan and its Metabolite ACT-132577 from Time Zero to 72 Hours (AUC [0-72 Hours]) Postdose | AUC (0-72 hours) is defined as area under the plasma analyte concentration-time curve of macitentan and its metabolite ACT-132577 from time zero to 72 hours postdose, calculated by linear-linear trapezoidal summation. | Predose up to 72 hours post dose |
| Apparent Terminal Elimination Half-life (t1/2) of Macitentan and its Metabolite ACT-132577 | t1/2 of macitentan and its metabolite ACT-132577 is time measured for the plasma analyte concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Predose and up to 216 hours post dose (Up to Day 10) |
| Apparent Terminal Elimination Rate Constant (Lambda[z]) of Macitentan and its Metabolite ACT-132577 | Lambda(z) of macitentan and its metabolite ACT-132577 is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve. | Predose and up to 216 hours post dose (Up to Day 10) |
| Total Apparent Oral Clearance (CL/F) of Macitentan and its Metabolite ACT-132577 | CL/F of macitentan and its metabolite ACT-132577 is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity). | Predose and up to 216 hours post dose (Up to Day 10) |
| Apparent Volume of Distribution (Vdz/F) of Macitentan and its Metabolite | Vdz/F of macitentan and its metabolite ACT-132577 is defined as apparent volume of distribution, calculated as dose/(Lambda[z]*AUC [0-infinity]). | Predose and up to 216 hours post dose (Up to Day 10) |
| Maximum Observed Plasma Analyte Concentration (Cmax) of Metabolite ACT-132577 | Cmax is defined as maximum observed plasma analyte concentration of metabolite ACT-132577. | Predose and up to 216 hours post dose (Up to Day 10) |
| Area Under the Plasma Analyte Concentration-Time Curve of Metabolite ACT-132577 from Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) | AUC (0-last) of metabolite ACT-132577 is defined as area under the plasma analyte concentration-time curve from time zero to time of the last quantifiable (BQL) concentration, calculated by linear-linear trapezoidal summation. | Predose and up to 216 hours post dose (Up to Day 10) |
| Area Under the Plasma Analyte Concentration-Time Curve of Metabolite ACT-132577 from Time Zero to Infinity (AUC [0-infinity]) | AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve of metabolite ACT-132577 from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), where AUC (0-last) is area under the plasma analyte concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) plasma analyte concentration and lambda(z) is apparent terminal elimination rate constant. | Predose and up to 216 hours post dose (Up to Day 10) |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. | Up to Week 10 |
| Number of Participants with Abnormalities in Physical Examination | Number of participants with abnormalities in physical examination (including general appearance, respiratory, neurological, eyes, ear/nose/throat, thyroid, cardiovascular, abdominal/gastrointestinal, hepatic, musculoskeletal, and dermatologic) will be reported. | Up to Day 10 of each treatment period (Up to 7 weeks) |
| Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (including temperature [tympanic], pulse rate, and blood pressure) will be reported. | Up to Day 10 of each treatment period (Up to 7 weeks) |
| Number of Participants with Abnormalities in Electrocardiograms (ECGs) | Number of participants with abnormalities in ECGs will be reported. | Up to Day 10 of each treatment period (Up to 7 weeks) |
| Number of Participants with Abnormalities in Clinical Laboratory Tests | Number of participants with abnormalities in clinical laboratory tests (such as serum chemistry, hematology, and urinalysis) will be reported. | Up to Day 10 of each treatment period (Up to 7 weeks) |