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

Drug Drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238948
• Other study ID #: A82_04DDI2124
• Secondary ID: 2021-006496-41
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2022
• Est. completion date: April 29, 2022

Study information

• Verified date: January 2022
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• Midazolam
Substrate of CYP3A4
• CKD-506
Perpetrator of CYP3A4

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of oral midazolam	With and without coadministration of CKD-506	For 24 hours
Primary	Area Under Curve (AUC) of oral midazolam	With and without coadministration of CKD-506	For 24 hours
Secondary	Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506		For 24 hours
Secondary	AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506		For 24 hours
Secondary	Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506		For 24 hours
Secondary	Number of treatment emergent adverse events	assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination	Over 4 weeks
Secondary	Number of participants with treatment emergent adverse events	assessed by clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination	Over 4 weeks