Drug-drug Interaction and Food-effect Study With GLPG4716... | NCT05030857

Studies
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects

NCT05030857

Sponsor

Lakefront Biotherapeutics NV

Status

Completed

Last Update Posted

Nov 24, 2021Actual

Enrollment

19Actual

Phase

Phase 1

Conditions

Healthy

Interventions

GLPG4716
Midazolam

Countries

Canada

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

Status Module

Record Verification Date

Nov 2021

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

Sep 8, 2021Actual

Primary Completion Date

Nov 13, 2021Actual

Completion Date

Nov 13, 2021Actual

First Submitted Date

Aug 30, 2021

First Submission Date that Met QC Criteria

Aug 30, 2021

First Posted Date

Sep 1, 2021Actual

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

Nov 23, 2021

Last Update Posted Date

Nov 24, 2021Actual

Description Module

Brief Summary

The purpose of this study is to determine the effect of the administration of multiple doses of GLPG4716 on the amount of midazolam (MDZ) that gets into the blood when the two drugs are administered together compared to when midazolam is administered alone. Other objectives of this study are to evaluate the safety and tolerability of GLPG4716 when administered with midazolam and assess the amount of GLPG4716 that gets into the blood when administered with midazolam. This study will also assess the effect of food on the amount of GLPG4716 that gets into the blood.

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

19Actual

Label	Type	Description	Intervention Names
GLPG4716 and Midazolam	Experimental		Drug: GLPG4716 Drug: Midazolam

Name	Type	Description	Arm Group Labels	Other Names
GLPG4716	Drug	From Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state.	GLPG4716 and Midazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed plasma concentration (Cmax) of MDZ	To determine the effect of GLPG4716 on the pharmacokinetics (PK) of MDZ	From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ	To determine the effect of GLPG4716 on the PK of MDZ	From Day 1 pre-dose until Day 15

Secondary Outcomes

Measure	Description	Time Frame
Cmax of GLPG4716	To assess the effect of food on the PK of GLPG4716.	From Day 1 pre-dose until Day 15
Area under the plasma concentration-time curve over the dosing interval (AUCt) of GLPG4716

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form. Female subjects should be of non-childbearing potential.
A body mass index between 18.0 and 30.0 kg/m2, inclusive.
Judged to be in good health by the investigator based upon:
- The results of a medical history
- Physical examination
- Vital signs
- Oxygen saturation
- 12-lead electrocardiogram
- Fasting clinical laboratory safety tests. Aspartate aminotransferase and alanine aminotransferase must be no greater than 1.5x upper limit of normal range and total bilirubin no greater than 1x upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

Known hypersensitivity to ingredients of GLPG4716 and/or MDZ
History of a significant allergic reaction to ingredients of GLPG4716 and/or MDZ as determined by the investigator.
Treatment with any medication including:
- Over-the-counter and/or prescription medication
- Dietary supplements
- Nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy
- Except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.

This list only contains the key exclusion criteria.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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