NCT03814200

A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects

A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of a Single Intravenous Dose of Rifampicin on the Pharmacokinetics of ACT-246475 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	Saline	Single i.v. infusion of 100 mL saline 0.9% for 30 min
DRUG	ACT-246475	Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions
DRUG	Rifampicin	Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min

Timeline

• Start date: 2019-01-03
• Primary completion: 2019-02-12
• Completion: 2019-02-19
• First posted: 2019-01-23
• Last updated: 2025-07-03

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study