Clincosm LogoSign in Get a demo

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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT05238948
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
2
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
One arm and 1-sequence crossoverOne arm and 1-sequence crossover
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
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
Actual Study Start Date :
Feb 28, 2022
Actual Primary Completion Date :
Apr 29, 2022
Actual Study Completion Date :
Apr 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Midazolam with/without CKD-506

Single arm and 1-sequence crossover

Drug: Midazolam
Substrate of CYP3A4
Other Names:
  • Single dose

    • Drug: CKD-506
    Perpetrator of CYP3A4
    Other Names:
  • Single and multiple dose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Plasma Concentration (Cmax) of oral midazolam [For 24 hours]

      With and without coadministration of CKD-506

    2. Area Under Curve (AUC) of oral midazolam [For 24 hours]

      With and without coadministration of CKD-506

    Secondary Outcome Measures

    1. Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506 [For 24 hours]

    2. AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506 [For 24 hours]

    3. Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506 [For 24 hours]

    4. Number of treatment emergent adverse events [Over 4 weeks]

      assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination

    5. Number of participants with treatment emergent adverse events [Over 4 weeks]

      assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 49 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PRA Health Sciences Groningen Netherlands 9728

    Sponsors and Collaborators

    • Chong Kun Dang Pharmaceutical

    Investigators

    • Principal Investigator: Maria Velinova,, MD, PhD, PRA Group BV, a PRA Health Sciences company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT05238948
    Other Study ID Numbers:
    • A82_04DDI2124
    • 2021-006496-41
    First Posted:
    Feb 14, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chong Kun Dang Pharmaceutical
    CYP3A4
    Midazolam
    Additional relevant MeSH terms:
    Midazolam

    Study Results

    No Results Posted as of Aug 25, 2022