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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Drug Drug Interaction

Intervention / Treatment
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* Drug: Midazolam
* Drug: CKD-506


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Sequential Assignment
Interventional Model Description: One arm and 1-sequence crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam with/without CKD-506<br>Single arm and 1-sequence crossover | Drug: Midazolam<br>* Substrate of CYP3A4<br>* Other names: Single dose;Drug: CKD-506<br>* Perpetrator of CYP3A4<br>* Other names: Single and multiple dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of oral midazolam | With and without coadministration of CKD-506 | For 24 hours | 
| Area Under Curve (AUC) of oral midazolam | With and without coadministration of CKD-506 | For 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CYP3A4, Midazolam