Open-label study to compare the bioavailability of an oral tablet of GLPG1972 relative to an oral solution after single-dose intake in healthy subjects and to evaluate the effect of food on the oral tablet.

Open-label study to compare the bioavailability of an oral tablet of GLPG1972 relative to an oral solution after single-dose intake in healthy subjects and to evaluate the effect of food on the oral tablet. - GLPG1972 BA study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42935

Enrollment

Registered

2016-03-30

Start date

2016-06-14

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Arthritis.

Interventions

Treatment A: 600 mg GLPG1972 as an oral solution after an overnight fast Treatment B: 600 mg GLPG1972 as oral tablets (2 tablets) after an overnight fast Treatment C: 600 mg GLPG1972 as oral tablets

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 50 years of age, inclusive BMI 18.0 - 30.0 kilograms/meter2 Body weight at least 50 kilograms non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 8 weeks before the start of this study or being a blood donor within 12 weeks 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.

Design outcomes

Primary

Measure	Time frame
To compare the PK of an oral tablet of GLPG1972 with an oral solution of GLPG1972 under fasted conditions. To evaluate the effect of food (high-fat, high calorie meal) on the PK of GLPG1972 administered as an oral tablet. To evaluate the safety and tolerability of single oral doses of GLPG1972.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)