An open-label, two-period, fixed sequence study to evaluate the effects of multiple oral doses of AFQ056 on the pharmacokinetics of a monophasic oral contraceptive in healthy female volunteers

Completed

• Conditions: Fragile X Syndrome (FXS); interaction study; mental retardation; 10083624; 10029305

• Registration Number: NL-OMON36456
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Healthy female subjects, 18 to 40 years of age, BMI 18 - 30 kg/m2, OC containing EES (30µg)/LVG (150µg) for a least of three cycles prior to screening.

Exclusion Criteria

Subjects that are pregnant, post-menopausal, breast-feeding or have stopped- breastfeeding less than 6 months before screening, smoker, clinically significant abnormalities during screening and baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effect of multiple oral doses of test compound (100 mg b.i.d.) on<br /><br>the PK of a single dose of a monophasic oral contraceptive (OC), containing<br /><br>ethinyl estradiol (30µg EES) and levonorgestrel (150µg LVG) in healthy female<br /><br>volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of multiple, oral doses of b.i.d. test<br /><br>compound in combination with a single dose of a monophasic OC in healthy female<br /><br>volunteers</p><br>