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A Phase I, open-label, drug-drug interaction study between multiple oral doses of GLPG1972 and a single dose of midazolam in healthy male subjects.

A Phase I, open-label, drug-drug interaction study between multiple oral doses of GLPG1972 and a single dose of midazolam in healthy male subjects. - DDI study between GLPG1972 and Midazolam in healthy male subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44611
Enrollment
18
Registered
2017-07-11
Start date
2017-07-17
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis.

Interventions

Treatment 1: a single dose of 2 mg midazolam on Day 1 (Day 1 is the first day of administration of the study compound) Treatment 2: a single dose of 300 mg GLPG1972 once daily for 10 days (from Day
Osteoarthritis

Sponsors

Galapagos NV
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male volunteers 18 - 50 years, inclusive BMI 18.0 - 30.0 kg/m2 weight at least 50 kilograms non smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study. Not allowed is the use of any prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g. St. John*s Wort), from 14 days prior to the first administration of the study compound until the post-study visit.

Design outcomes

Primary

MeasureTime frame
To assess the effect of multiple oral doses of GLPG1972 (300 mg q.d.) on the single oral dose PK of midazolam (2 mg) in healthy male subjects.

Secondary

MeasureTime frame
To evaluate the safety and tolerability of multiple oral doses of GLPG1972 administered with a single oral dose of midazolam or without midazolam in healthy male subjects.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)