- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05959941
A Study of Macitentan in Healthy Chinese Adult Male Participants
July 18, 2023 updated by: Actelion
A Double-blind, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Macitentan 75 mg in Healthy Chinese Adult Male Participants
The purpose of this study is to assess what macitentan and its active metabolite (aprocitentan) does to the body after single dose administration of macitentan in Chinese healthy adult male participants.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study@its.jnj.com
Study Locations
-
-
-
Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Chinese Male
- Be health medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiograms (ECG) performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
- Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- Body mass index (weight /height^2) between 18.0 and 27.9 kilograms per meter square (kg/m^2) (inclusive), and body weight not less than 50.0 kg
- Systolic blood pressure (BP) was between 100 and 140 millimeter of mercury (mmHg) and for diastolic BP - between 60 and 90 mmHg (after the participant is supine for 5 minutes and including boundary values)
- A 12-lead ECG consistent with normal cardiac conduction and function
- A participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study intervention
- Must sign an ICF indicating that he understands the purpose of, and procedures required for the study and is willing to participate in the study
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 80 milliliters per minute (mL/min) calculated using Cockcroft-Gault equation), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
- One or more of the following laboratory abnormalities at screening, defined as Grade 1 or more by the World Health Organisation (WHO )Toxicity Grading Scale for Determining the Severity of Adverse Events, February 2003: aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than or equal to (>=)1.25x upper limit of normal (ULN); Total bilirubin >=1.25x ULN; Hemoglobin less than or equal to (<=)11 grams per deciliter (g/dL)
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin or malignancy, which is considered cured with minimal risk of recurrence)
- Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen within 14 days before the first dose of the study intervention is scheduled until completion of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Macitentan 75 milligrams (mg)
Healthy participants will receive a single-dose of macitentan 75 mg tablet on Day 1 under fed condition.
|
Macitentan tablet will be administered orally.
Other Names:
|
Experimental: Placebo
Healthy participants will receive matching placebo tablet on Day 1 under fed condition.
|
Placebo will be administered orally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
|
Cmax is the maximum observed plasma concentration of macitentan and aprocitentan.
|
Pre dose up to 336 hours post dose on Day 1
|
Time to Maximum Observed Plasma Concentration (Tmax) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
|
Tmax is the time to reach maximum observed plasma concentration of macitentan and aprocitentan.
|
Pre dose up to 336 hours post dose on Day 1
|
Area Under the Plasma Concentration Time Curve from Time Zero to Time of the Last Quantifiable Concentration (AUC [0-Last]) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
|
AUC (0-Last) is the area under the plasma concentration time curve from time 0 to time of the last measurable concentration of macitentan and aprocitentan.
|
Pre dose up to 336 hours post dose on Day 1
|
Area Under the Plasma Concentration Time Curve from Time Zero to Infinite time (AUC [0-Infinity]) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
|
AUC (0-Infinity) is the area under the plasma concentration time curve from time 0 to infinite time of macitentan and aprocitentan.
|
Pre dose up to 336 hours post dose on Day 1
|
Apparent Elimination Half-Life (t1/2) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
|
t1/2 is the apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of macitentan and aprocitentan.
|
Pre dose up to 336 hours post dose on Day 1
|
Total Systemic Clearance (CL/F) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
|
CL/F is the total systemic clearance following single-dose extravascular administration of macitentan and aprocitentan.
|
Pre dose up to 336 hours post dose on Day 1
|
Apparent Volume of Distribution (Vz/F) of Macitentan and Aprocitentan
Time Frame: Pre dose up to 336 hours post dose on Day 1
|
Vz/F is the apparent volume of distribution based on terminal phase of macitentan and aprocitentan.
|
Pre dose up to 336 hours post dose on Day 1
|
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 9 weeks
|
An 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 causal relationship with the intervention.
|
Up to 9 weeks
|
Number of Participants with Adverse Events of Special Interest (AESI)
Time Frame: Up to 9 weeks
|
Number of participants with AESIs will be reported.
AESIs includes hypotension, anemia, edema, and liver events.
|
Up to 9 weeks
|
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to 9 weeks
|
Number of participants with SAEs will be reported.
A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.
|
Up to 9 weeks
|
Number of Participants with Clinical Laboratory Tests Abnormalities
Time Frame: Up to 9 weeks
|
Number of participants with clinical laboratory tests (including serum chemistry, hematology, and urinalysis) abnormalities will be reported.
|
Up to 9 weeks
|
Number of Participants with Vital Signs Abnormalities
Time Frame: Up to 9 weeks
|
Number of participants with vital signs (blood pressure, pulse rate, respiratory rate, and temperature [ear or axillary]) abnormalities will be reported.
|
Up to 9 weeks
|
Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time Frame: Up to 9 weeks
|
Number of participants with 12-lead ECG abnormalities will be reported.
|
Up to 9 weeks
|
Number of Participants with Physical Examinations Abnormalities
Time Frame: Up to 9 weeks
|
Number of participants with physical examinations abnormalities will be reported.
|
Up to 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Actelion Clinical Trial, Actelion
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2023
Primary Completion (Estimated)
September 29, 2023
Study Completion (Estimated)
September 29, 2023
Study Registration Dates
First Submitted
July 18, 2023
First Submitted That Met QC Criteria
July 18, 2023
First Posted (Actual)
July 25, 2023
Study Record Updates
Last Update Posted (Actual)
July 25, 2023
Last Update Submitted That Met QC Criteria
July 18, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR109324
- 67896062PAH1009 (Other Identifier: Actelion)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States