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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-04-29

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.

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Detailed Description

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Conditions

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Drug Drug Interaction

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

One arm and 1-sequence crossover

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Midazolam with/without CKD-506

Single arm and 1-sequence crossover

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Substrate of CYP3A4

CKD-506

Intervention Type DRUG

Perpetrator of CYP3A4

Interventions

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Midazolam

Substrate of CYP3A4

Intervention Type DRUG

CKD-506

Perpetrator of CYP3A4

Intervention Type DRUG

Other Intervention Names

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Single dose Single and multiple dose

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