A Study of Macitentan in Healthy Chinese Adult Male Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959941
• Other study ID #: CR109324
• Secondary ID: 67896062PAH1009
• Status: Recruiting
• Phase: Phase 1
• Start date: July 5, 2023
• Est. completion date: September 29, 2023

Study information

• Verified date: July 2023
• Source: Actelion
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Macitentan
Macitentan tablet will be administered orally.
• Placebo
Placebo will be administered orally.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Macitentan and Aprocitentan	Cmax is the maximum observed plasma concentration of macitentan and aprocitentan.	Pre dose up to 336 hours post dose on Day 1
Primary	Time to Maximum Observed Plasma Concentration (Tmax) of Macitentan and Aprocitentan	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
Primary	Area Under the Plasma Concentration Time Curve from Time Zero to Time of the Last Quantifiable Concentration (AUC [0-Last]) of Macitentan and Aprocitentan	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
Primary	Area Under the Plasma Concentration Time Curve from Time Zero to Infinite time (AUC [0-Infinity]) of Macitentan and Aprocitentan	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
Primary	Apparent Elimination Half-Life (t1/2) of Macitentan and Aprocitentan	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
Primary	Total Systemic Clearance (CL/F) of Macitentan and Aprocitentan	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
Primary	Apparent Volume of Distribution (Vz/F) of Macitentan and Aprocitentan	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
Primary	Number of Participants with Adverse Events (AEs)	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
Primary	Number of Participants with Adverse Events of Special Interest (AESI)	Number of participants with AESIs will be reported. AESIs includes hypotension, anemia, edema, and liver events.	Up to 9 weeks
Primary	Number of Participants with Serious Adverse Events (SAEs)	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
Primary	Number of Participants with Clinical Laboratory Tests Abnormalities	Number of participants with clinical laboratory tests (including serum chemistry, hematology, and urinalysis) abnormalities will be reported.	Up to 9 weeks
Primary	Number of Participants with Vital Signs Abnormalities	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
Primary	Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities	Number of participants with 12-lead ECG abnormalities will be reported.	Up to 9 weeks
Primary	Number of Participants with Physical Examinations Abnormalities	Number of participants with physical examinations abnormalities will be reported.	Up to 9 weeks