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Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics

NCT03389321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-02-08

No results posted yet for this study

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

Interventions

DRUG

Riociguat (Adempas)

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

DRUG

Macitentan (Opsumit)

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

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Shirin Bruderer, PhD · Actelion

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2018-02-06
Completion
2018-02-06

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389321 on ClinicalTrials.gov