Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics

NCT ID: NCT03389321

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-09
• Study Completion Date: 2018-02-06

Brief Summary

Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension (PAH) and may be administered concomitantly. The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK) (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat in healthy male subjects.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A-B

All subjects will receive treatment A followed by treatment B. Treatment A consists of a single oral dose (1 mg) of riociguat (Adempas) on Day 1. Treatment B consists of a loading oral dose of 30 mg macitentan (Opsumit) (3 tablets of 10 mg) on Day 5, then 10 mg of macitentan once daily from Day 6 to Day 15, with a concomitant administration of riociguat (1 mg) on Day 10.

Group Type: EXPERIMENTAL

Riociguat (Adempas)

Intervention Type: DRUG

Riociguat film-coated tablets for oral administration at a strength of 1 mg

Macitentan (Opsumit)

Intervention Type: DRUG

Macitentan film-coated tablets for oral administration at a strength of 10 mg

Interventions

Riociguat (Adempas)

Riociguat film-coated tablets for oral administration at a strength of 1 mg

Intervention Type: DRUG

Macitentan (Opsumit)

Macitentan film-coated tablets for oral administration at a strength of 10 mg

Intervention Type: DRUG

Other Intervention Names

ACT-064992

Eligibility Criteria

Inclusion Criteria

• Male subjects aged between 18 and 45 years (inclusive) at screening who signed informed consent prior to any study-mandated procedure;
• Healthy on the basis of physical examination, cardiac evaluations (12-lead ECG) and laboratory tests performed at screening;
• Body mass index of 18 to 30 Kg/m2 (inclusive) at screening;
• Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 50-90 beats per minute (inclusive).

Exclusion Criteria

• Known allergic reactions or hypersensitivity to macitentan, riociguat, any drug of the same classes, or any of their excipients;
• Any contraindication for riociguat treatment;
• Known hypersensitivity or allergy to natural rubber latex;
• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions;
• History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatments;
• Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration;
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shirin Bruderer, PhD

Role: STUDY_DIRECTOR

Actelion

Locations

CRS Clinical Research Services Mannheim

Mannheim, , Germany

Countries

Germany

Other Identifiers

2017-003502-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-055-123

Identifier Type: -

Identifier Source: org_study_id