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

August 24, 2022 updated by: Chong Kun Dang Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of oral midazolam
Time Frame: For 24 hours
With and without coadministration of CKD-506
For 24 hours
Area Under Curve (AUC) of oral midazolam
Time Frame: For 24 hours
With and without coadministration of CKD-506
For 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Time Frame: For 24 hours
For 24 hours
AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506
Time Frame: For 24 hours
For 24 hours
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
For 24 hours
Number of treatment emergent adverse events
Time Frame: Over 4 weeks
assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination
Over 4 weeks
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
Over 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A82_04DDI2124
  • 2021-006496-41 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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