Clinical trial NCT02562950: A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects
Official title: A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2015-09-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
timeFrame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
measure: The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
timeFrame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
measure: The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
timeFrame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
measure: The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
timeFrame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
Secondary outcomes:
measure: The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
timeFrame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
measure: Number of adverse events
timeFrame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
measure: Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature
timeFrame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
measure: Changes in 12-lead ECG measures
timeFrame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
measure: Changes in physical exam measures
timeFrame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
measure: Changes in blood safety lab parameters
timeFrame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
measure: Changes in urine safety lab parameters
timeFrame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
measure: The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
timeFrame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
measure: The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
timeFrame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
measure: The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
timeFrame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
measure: The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
timeFrame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerp
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References: