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

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Drug Drug Interaction

Treatments: Drug: Midazolam; Drug: CKD-506

Study type: Interventional

Funder types: Industry

Identifiers

NCT05238948

2021-006496-41 (EudraCT Number)

A82_04DDI2124

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Male

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Midazolam with/without CKD-506

Experimental group

Description:

Single arm and 1-sequence crossover

Treatment:

Drug: CKD-506

Drug: Midazolam