NCT05238948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

August 25, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 11, 2022

Last Update Submit

August 24, 2022

Conditions

Drug Drug Interaction

Keywords

CYP3A4Midazolam

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration (Cmax) of oral midazolam

    With and without coadministration of CKD-506

    For 24 hours

  • Area Under Curve (AUC) of oral midazolam

    With and without coadministration of CKD-506

    For 24 hours

Secondary Outcomes (5)

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

    For 24 hours

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

    For 24 hours

  • Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506

    For 24 hours

  • Number of treatment emergent adverse events

    Over 4 weeks

  • Number of participants with treatment emergent adverse events

    Over 4 weeks

Study Arms (1)

Midazolam with/without CKD-506

EXPERIMENTAL

Single arm and 1-sequence crossover

Drug: MidazolamDrug: CKD-506

Interventions

MidazolamDRUG

Substrate of CYP3A4

Also known as: Single dose
Midazolam with/without CKD-506
CKD-506DRUG

Perpetrator of CYP3A4

Also known as: Single and multiple dose
Midazolam with/without CKD-506

Eligibility Criteria

Age20 Years - 49 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male subjects are eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of relevant drug and/or food allergies.
  • Using tobacco products
  • Positive drug and alcohol screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences

Groningen, 9728, Netherlands

Location

MeSH Terms

Interventions

MidazolamCKD-506Single Person

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Maria Velinova,, MD, PhD

    PRA Group BV, a PRA Health Sciences company

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: One arm and 1-sequence crossover
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 14, 2022

Study Start

February 28, 2022

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

August 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)