NCT04540744

A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil

A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess the Relative Oral Bioavailability of the Combination of Macitentan/Tadalafil (10 mg/20 mg) Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of 10 mg Macitentan (Opsumit®) and 20 mg Tadalafil (Adcirca®)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the rate and extent of absorption of macitentan and tadalafil following administration of a single oral dose of a fixed-dose combination (FDC) of 10 milligram (mg)/20 mg macitentan/tadalafil (test), compared to the coadministration as a free combination (reference) of 10 mg macitentan and 20 mg tadalafil under fasted conditions in healthy adult participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	FDC of macitentan/tadalafil (10 mg/20 mg)	FDC of macitentan/tadalafil (10 mg/20 mg) tablet will be administered orally as per assigned treatment sequence.
DRUG	Macitentan 10 mg	Macitentan 10 mg tablet will be administered orally as a free combination as per assigned treatment sequence.
DRUG	Tadalafil 20 mg	Tadalafil 20 mg tablet will be administered orally as a free combination as per assigned treatment sequence.

Timeline

• Start date: 2021-04-30
• Primary completion: 2021-08-08
• Completion: 2021-08-30
• First posted: 2020-09-07
• Last updated: 2025-03-30

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study