NCT05123820

Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470

A Single-center, Open-label, Two-period, Fixed-sequence Study to Investigate the Effect of a Single Oral Dose of ACT-1014-6470 on the Pharmacokinetics of Omeprazole, Midazolam, and Their Metabolites in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A study on whether ACT-1014-6470 has an effect on how the body takes up, distributes and gets rid of omeprazole and midazolam in healthy male subjects

Conditions

• Drug Drug Interaction
• Healthy

Interventions

Type	Name	Description
DRUG	Treatment period A	Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.
DRUG	Treatment period B	ACT-1014-6470 soft capsule for oral administration. Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.

Timeline

• Start date: 2021-11-13
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2021-11-17
• Last updated: 2022-01-14

Locations

1 site across 1 country: Czechia