A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

NCT02562950 | Completed Phase 1

• 2 other identifiers: GLPG1837-CL-1022015-002517-29
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11). Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated. A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837

  To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects

  Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

• The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837

  To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects

  Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

• The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837

  To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects

  Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

• The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837

  To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects

  Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

Secondary Outcomes (11)

• The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)

  Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

• Number of adverse events

  Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

• Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature

  Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

• Changes in 12-lead ECG measures

  Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

• Changes in physical exam measures

  Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

Study Arms (2)

Midazolam and 500 mg GLPG1837

EXPERIMENTAL

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.

Drug: GLPG1837 500 mg; Drug: Midazolam

Midazolam and 1000 mg GLPG1837

EXPERIMENTAL

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.

Drug: Midazolam; Drug: GLPG1837 1000 mg

Interventions

GLPG1837 500 mg DRUG

Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.

Midazolam and 500 mg GLPG1837

Midazolam DRUG

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).

Midazolam and 1000 mg GLPG1837; Midazolam and 500 mg GLPG1837

GLPG1837 1000 mg DRUG

Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.

Midazolam and 1000 mg GLPG1837

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male, age 18-50 years
• BMI between 18-30 kg/m2

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)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Location

MeSH Terms

Interventions

GLPG1837; 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

BE (1)