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

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.

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