A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects

Lakefront Biotherapeutics NV20 enrolled

Overview

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days). Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

GLPG0634DRUG

Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.

MidazolamDRUG

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)

Eligibility

Sex: MALEMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * male, between 40 and 60 years of age, inclusive * within BMI range 18 to 30 kg/m2, inclusive Exclusion Criteria: * Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking

Locations (1)

Covance Clinical Research Unit

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

The amount of (1'-OH) Midazolam in plasma over time before and after multiple oral doses of GLPG0634

To characterize the amount of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG0634 - pharmacokinetics (PK) - in healthy subjects

Time frame: Between predose and up to 24h postdose on Day 1 and Day 8

Secondary Outcomes

The amount of GLPG0634 and metabolite in plasma over time after multiple oral doses of GLPG0634 (and co-administration of Midazolam on Day 8)

To characterize the amount of GLPG0634 and metabolite in plasma over time after multiple doses of GLPG0634 (and co-administration of Midazolam on Day 8) - pharmacokinetics (PK) - in healthy subjects

Time frame: Between predose (Day 2) and up to 96h after the last dose on Day 8 (on Day 12)

Number of adverse events

To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of the number of adverse events reported

Time frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)

Changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate only 1 hour post Midazolam dosing)

To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate) reported

Time frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)

Changes in 12-lead ECG measures

To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported

Data from ClinicalTrials.gov

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