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.

Completed

Conditions: Taaislijmziekte, cystische fibrose
cystic fibrosis

Registration Number: NL-OMON42997

Lead Sponsor: Galapagos SAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

healthy sterilized women or healthy postmenopausal women
18 - 65 years, inclusive
BMI 18.0 - 30.0 kg/m2
non-smoking

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>To characterize the PK of GLPG2451 after single and multiple oral<br /><br>administrations.<br /><br>To characterize the PK of GLPG2451 and GLPG2222 when given concomitantly.<br /><br>To explore the potential of CYP3A4 interaction by repeated dosing with<br /><br>GLPG2451.</p><br>