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

NCT01798979 | Completed Phase 1

• 1 other identifier: GLPG0634-CL-103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (7)

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

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

• Number of adverse events

  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)

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

• Changes in 12-lead ECG measures

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

• Changes in physical exam measures

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

Study Arms (1)

Midazolam and GLPG0634

EXPERIMENTAL

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8) and multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.

Drug: GLPG0634; Drug: Midazolam

Interventions

GLPG0634 DRUG

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

Midazolam and GLPG0634

Midazolam DRUG

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

Midazolam and GLPG0634

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male, between 40 and 60 years of age, inclusive
• within BMI range 18 to 30 kg/m2, inclusive

You may not qualify if:

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

GLPG0634; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Frédéric Vanhoutte, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2013
• First Posted: February 26, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

US (1)