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.
- Conditions
- ung fibrosisPulmonary fibrosisScarring of the lungs
- Registration Number
- NL-OMON51608
- Lead Sponsor
- Chong Kun Dang Pharmaceutical Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the effect of single and multiple oral doses of CKD-506 on the<br /><br>single-dose PK of oral midazolam when co-administered in healthy male<br /><br>subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the PK of CKD-506 and its metabolites CKD-506 acid (M2) and CKD-506<br /><br>amide (M3) following single and multiple doses of CKD-506 administered as oral<br /><br>tablets<br /><br><br /><br>- To assess the safety and tolerability of CKD-506 when co-administered with<br /><br>midazolam</p><br>