Overview

TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to investigate the pharmacokinetic interaction between the combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. Furthermore the short-term safety and tolerability (how well the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and norethindrone, in healthy women, will be assessed.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Treatments:
Ethinyl Estradiol
Mestranol
Norethindrone
Norethindrone acetate
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Norinyl
Rilpivirine
Criteria
Inclusion Criteria:

- Willing to start or continue oral contraceptive therapy, specifically ethinylestradiol
and norethindrone, for the duration of the study

- Consent to a method of birth control in addition to the OC trial medication

- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for
at least 3 months prior to screening

- Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included

- Healthy on the basis of a physical examination, medical history, electrocardiogram,
vital signs and the results of blood biochemistry and hematology tests and a
urinalysis carried out at screening.

Exclusion Criteria:

- The most important eligibility criteria are: Not pregnant or breastfeeding

- Not postmenopausal

- No positive HIV test

- No alcohol or barbiturate, amphetamine, recreational or narcotic drug use

- No hepatitis A, B or C infection

- No currently active gastrointestinal, cardiovascular, neurologic, psychiatric,
metabolic, renal, hepatic, respiratory, inflammatory or infectious disease

- No history of significant skin disease

- No previously demonstrated clinically significant allergy or hypersensitivity to any
of the excipients of the medication administered in this trial (i.e. TMC278, Ovysmen®)

- No clinical significant abnormal finding in the gynaecological examination

- No currently active gynaecological disorders

- No major medical condition that would preclude the safe administration of oral
contraceptive therapy

- No participation in an investigational drug trial within 60 days prior to the start of
the first OC cycle