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

NCT00739622 | Completed Phase 1

• 1 other identifier: CR010762
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV; AIDS; Oral Contraceptive

Keywords

TMC278-TiDP6-C136; TMC278-C136; Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine the effect of steady-state concentrations of TMC278 25 mg once daily on the steady-state pharmacokinetics of ethinylestradiol 35 mcg and norethindrone 1 mg once daily.

Secondary Outcomes (1)

• The secondary objective of this study is to evaluate the short-term safety and tolerability of coadministration of TMC278 and ethinylestradiol and norethindrone OC in healthy women.

Interventions

TMC278 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Publications (1)

• Crauwels HM, van Heeswijk RP, Buelens A, Stevens M, Hoetelmans RM. Lack of an effect of rilpivirine on the pharmacokinetics of ethinylestradiol and norethindrone in healthy volunteers. Int J Clin Pharmacol Ther. 2014 Feb;52(2):118-28. doi: 10.5414/CP201943.

  PMID: 24161160 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Rilpivirine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals Limited Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 28, 2010

Record last verified: 2010-04