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Completed

NCT Number: NCT05238948

CKD-506 Drug-Drug Interaction Study 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.

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Key information

Conditions

Drug Drug Interaction

Age range

20 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, 9728, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Substrate of CYP3A4

Other names: Single dose

CKD-506

Drug

Perpetrator of CYP3A4

Other names: Single and multiple dose

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of oral midazolam

    Time frame: For 24 hours

    With and without coadministration of CKD-506

  2. Area Under Curve (AUC) of oral midazolam

    Time frame: For 24 hours

    With and without coadministration of CKD-506

Secondary outcomes

  1. Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506

    Time frame: For 24 hours

  2. AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506

    Time frame: 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

    Time frame: For 24 hours

  4. Number of treatment emergent adverse events

    Time frame: Over 4 weeks

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

  5. Number of participants with treatment emergent adverse events

    Time frame: Over 4 weeks

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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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