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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05238948

Enrollment

Registered

2022-02-14

Start date

2022-02-28

Completion date

2022-04-29

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Drug Interaction

Keywords

CYP3A4, Midazolam

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.

Interventions

DRUGMidazolam

Substrate of CYP3A4

DRUGCKD-506

Perpetrator of CYP3A4

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

One arm and 1-sequence crossover

Eligibility

Sex/Gender

MALE

Age

20 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Number of 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	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026