Assessment of safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of GLPG2451 and of the combination of GLPG2451 and GLPG2222 in healthy female subjects.

Assessment of safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of GLPG2451 and of the combination of GLPG2451 and GLPG2222 in healthy female subjects. - GLPG2451 SAD/MAD Study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42997

Enrollment

Registered

2016-05-17

Start date

2016-06-01

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

Taaislijmziekte, cystische fibrose cystic fibrosis

Interventions

Cohort C Day 1 to 14 GLPG2451 15 mg (administered as 15 mg once daily or 7.5 mg twice daily) or placebo Cohort D Day 1 to 14 GLPG2451 45 mg (administered as 45 mg once daily or 22.5 mg twice daily)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy sterilized women or healthy postmenopausal women 18 - 65 years, inclusive BMI 18.0 - 30.0 kg/m2 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 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.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single ascending oral doses (SAD) of GLPG2451 given to healthy female subjects, compared to placebo. To evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG2451 given to healthy female subjects daily for 14 days, compared to placebo. To evaluate the safety and tolerability of two combined doses of GLPG2451 and GLPG2222 given to healthy female subjects for 14 days, compared to placebo.	—

Measure

Time frame

To evaluate the safety and tolerability of single ascending oral doses (SAD) of GLPG2451 given to healthy female subjects, compared to placebo. To evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG2451 given to healthy female subjects daily for 14 days, compared to placebo. To evaluate the safety and tolerability of two combined doses of GLPG2451 and GLPG2222 given to healthy female subjects for 14 days, compared to placebo.

—

Secondary

Measure	Time frame
To characterize the PK of GLPG2451 after single and multiple oral administrations. To characterize the PK of GLPG2451 and GLPG2222 when given concomitantly. To explore the potential of CYP3A4 interaction by repeated dosing with GLPG2451.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)