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

Phase 1

Completed

• Conditions: Drug Drug Interaction
• Interventions: Drug: Midazolam; Drug: CKD-506

• Registration Number: NCT05238948
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-14
• Study Start: 2022-02-28
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

• Healthy male subjects
• Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks)
• Ability and willingness to abstain from foods and beverages containing grapefruit, Seville oranges, pomelos, star fruit, or cranberries

Exclusion Criteria

• History of relevant drug and/or food allergies.
• Using tobacco products
• Positive drug and alcohol screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Midazolam with/without CKD-506	CKD-506	Single arm and 1-sequence crossover
Midazolam with/without CKD-506	Midazolam	Single arm and 1-sequence crossover

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of oral midazolam	For 24 hours	With and without coadministration of CKD-506
Area Under Curve (AUC) of oral midazolam	For 24 hours	With and without coadministration of CKD-506

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506	For 24 hours
Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506	For 24 hours
Number of participants with treatment emergent adverse events	Over 4 weeks	assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination
AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506	For 24 hours
Number of treatment emergent adverse events	Over 4 weeks	assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination

Trial Locations

Locations (1)

PRA Health Sciences; 🇳🇱 Groningen, Netherlands