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.

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. - CKD-506 DDI study with midazolam.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51608

Enrollment

Registered

2021-12-27

Start date

2022-02-07

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Lung fibrosis Pulmonary fibrosis Scarring of the lungs

Interventions

Below an overview of the planned study compound administrations: Midazolam Day 1: 2 mg once Day 3: 2 mg once Day 16: 2 mg once CKD-506: Day 3: 200 mg once Day 4-15: 200 mg twice daily Dat 16: 200 mg

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Sex : Male. 2. Age : 20 to 49 years, inclusive, at screening. 3. Body mass index : 18.0 to 30.0 kg/m2, inclusive, at screening. 4. Weight : >=50 kg at screening. 5. Status : Healthy subjects. 6. Race : Caucasian only (ie, a white person having origins in any of the original peoples of Europe, the Middle East, or North Africa). + Further criteria apply, see protocol.

Exclusion criteria

Exclusion criteria: 1. Previous participation in the current study. 2. Employee of PRA or the Sponsor. 3. History of relevant drug and/or food allergies. 4. Using tobacco products within 60 days prior to the first drug administration. 5. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 2 years prior to admission to the clinical research center. + Further criteria apply, see protocol.

Design outcomes

Primary

Measure	Time frame
To assess the effect of single and multiple oral doses of CKD-506 on the single-dose PK of oral midazolam when co-administered in healthy male subjects.	—

Secondary

Measure	Time frame
- To assess the PK of CKD-506 and its metabolites CKD-506 acid (M2) and CKD-506 amide (M3) following single and multiple doses of CKD-506 administered as oral tablets - To assess the safety and tolerability of CKD-506 when co-administered with midazolam	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

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.