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

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 - CAFQ056A2133

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36456

Enrollment

Registered

2010-10-07

Start date

2010-10-15

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Fragile X Syndrome (FXS) interaction study mental retardation

Interventions

30 healthy female subjects will participate in this trial. On day 1 and 18 an oral contraceptive tablet will be administered. On day 9, 25mg test compound will be administered twice daily, on day 10

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assess the safety and tolerability of multiple, oral doses of b.i.d. test compound in combination with a single dose of a monophasic OC in healthy female volunteers	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)