NCT03596294

A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan

A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Clazosentan	Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h
DRUG	Rifampicin	Single i.v. dose of 600 mg rifampicin for 30 min
OTHER	Saline (0.9% sodium chloride)	Single i.v infusion of 500 mL saline for 30 min

Timeline

• Start date: 2018-07-19
• Primary completion: 2018-08-03
• Completion: 2018-08-03
• First posted: 2018-07-23
• Last updated: 2018-10-23

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study