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

NCT05238948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-08-25

No results posted yet for this study

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.

Conditions

  • Drug Drug Interaction

Interventions

DRUG

Midazolam

Substrate of CYP3A4

DRUG

CKD-506

Perpetrator of CYP3A4

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Maria Velinova,, MD, PhD · PRA Group BV, a PRA Health Sciences company

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-04-29
Completion
2022-04-29

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238948 on ClinicalTrials.gov