CKD-506 Drug-Drug Interaction Study in Healthy Male Subjects | NCT05238948

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

NCT05238948

Sponsor

Chong Kun Dang Pharmaceutical

Status

Completed

Last Update Posted

Aug 25, 2022Actual

Enrollment

17Actual

Phase

Phase 1

Conditions

Drug Drug Interaction

Interventions

Midazolam
CKD-506

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2021-006496-41	EudraCT Number

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2022Actual

Primary Completion Date

Apr 29, 2022Actual

Completion Date

Apr 29, 2022Actual

First Submitted Date

Jan 11, 2022

First Submission Date that Met QC Criteria

Feb 3, 2022

First Posted Date

Feb 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2022

Last Update Posted Date

Aug 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Midazolam with/without CKD-506	Experimental	Single arm and 1-sequence crossover	Drug: Midazolam Drug: CKD-506

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Midazolam	Drug	Substrate of CYP3A4	Midazolam with/without CKD-506	Single dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only male subjects are eligible.

Minimum Age

20 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Velinova,, MD, PhD	PRA Group BV, a PRA Health Sciences company	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PRA Health Sciences		Groningen		9728	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam
C000720039	CKD-506
D012847	Single Person

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided