NCT05238948

CKD-506 Drug-Drug Interaction Study in Healthy Male Subjects

A Phase 1, Open-label, 1-sequence Crossover Drug-drug-interaction Study to Assess the Effect of Single and Multiple Doses of CKD-506 on the Single-Dose Pharmacokinetics of Midazolam, A CYP3A4 Substrate, in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16 healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4 substrate in this study.

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	Midazolam	Substrate of CYP3A4
DRUG	CKD-506	Perpetrator of CYP3A4

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-04-29
• Completion: 2022-04-29
• First posted: 2022-02-14
• Last updated: 2022-08-25

Locations

1 site across 1 country: Netherlands