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- Klinische proef NCT00739622
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.
A Phase I, Open-label Drug-drug Interaction Trial to Investigate the Effect of TMC278 25 mg q.d. on the Steady State Pharmacokinetics of Ethinylestradiol and Norethindrone, in Healthy Women
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Human immunodeficiency virus (HIV)-infected patients are routinely being treated with combinations of 3 or 4 drugs (highly active antiretroviral therapy [HAART]), to reduce the risk of viral resistance development. Development of new potent antiretroviral (ARV) drugs is urgently needed to prolong suppression of viral replication in patients infected with HIV. This is a Phase I, open-label trial in healthy women to investigate the pharmacokinetic interaction between the combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily. The trial aims to allow further recommendations regarding the concurrent use of oral contraceptives and TMC278. The trial population will consist of 18 healthy women who are stable on oral contraceptives (OC), specifically ethinylestradiol and norethindrone, or who, if they are not currently using this OC, are willing to start or switch to this OC for the duration of the study.
Healthy volunteers will receive the OC once daily for 21 days for at least 1 OC cycle prior to Day 1 [stabilizing OC cycle from Day -28 to Day -1]. During the second OC cycle [from Day 1 to Day 28], subjects will receive the OC alone once daily for 21 days [Treatment A]. During the third OC cycle [from Day 29 to 56], subjects will receive the OC once daily for 21 days and in addition TMC278 25 mg q.d. in the morning for 15 days, starting on the first day of OC intake (Day 29) [Treatment B]. Full 24-hour pharmacokinetic profiles of ethinylestradiol and norethindrone will be determined after the first 2 weeks of the second OC cycle (Treatment A: OC alone; Day 15) and after the first 2 weeks of the third OC cycle (Treatment B: OC+TMC278; Day 43). A full 24-hour pharmacokinetic profile of TMC278 will be determined on Day 43. Blood samples on these days will be drawn just before drug intake (predose), and at 0.5, 1, 1.5, 2, 3, 4, 5 (Day 43 only), 6, 9, 12, 16 (Day 43 only) and 24 hours postdose. Safety evaluations include evaluation of adverse events, physical examination including vital signs, ECGs and laboratory hematology and biochemistry assessments. Healthy volunteers will receive a tablet of ethinylestradiol and norethindrone OC once daily for 21 days for at least 1 OC cycle prior to Day 1. During the second OC cycle, healthy volunteers will receive a tablet of ethinylestradiol and norethindrone OC alone once daily for 21 days. During the third OC cycle, healthy volunteers will receive a tablet of ethinylestradiol and norethindrone once daily for 21 days and in addition a tablet of TMC278 25 mg once daily in the morning for 15 days.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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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.
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Secundaire uitkomstmaten
Uitkomstmaat |
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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.
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR010762
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Hiv
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University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthWervingHiv | HIV-testen | Hiv-koppeling naar zorg | HIV-behandelingVerenigde Staten
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ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement; Centre Pasteur du Cameroun en andere medewerkersOnbekendHiv | HIV-niet-geïnfecteerde kinderen | Kinderen blootgesteld aan HIVKameroen
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationVoltooidPartner hiv-testen | HIV-counseling voor koppels | Paar communicatie | HIV-incidentieKameroen, Dominicaanse Republiek, Georgië, Indië
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University of MinnesotaIngetrokkenHIV-infecties | Hiv/aids | Hiv | AIDS | Aids/Hiv probleem | AIDS en infectiesVerenigde Staten
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Erasmus Medical CenterNog niet aan het wervenHIV-infecties | Hiv | HIV-1-infectie | HIV I-infectieNederland
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University of Maryland, BaltimoreIngetrokkenHiv | Niertransplantatie | HIV-reservoir | CCR5Verenigde Staten
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Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... en andere medewerkersWervingHiv | HIV-testen | Koppeling aan zorgZuid-Afrika
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Hospital Clinic of BarcelonaVoltooidIntegrase-remmers, HIV; HIV PROTEASE INHIBSpanje
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National Taiwan UniversityWerving
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Helios SaludViiV HealthcareOnbekendHiv | HIV-1-infectieArgentinië
Klinische onderzoeken op TMC278
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Janssen Research & Development, LLCVoltooid
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Tibotec Pharmaceuticals, IrelandVoltooid
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City of Hope Medical CenterNational Cancer Institute (NCI)VoltooidNiet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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University of California, San FranciscoNational Cancer Institute (NCI)OnbekendNierkankerVerenigde Staten
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)VoltooidLymfoom | Leukemie | Niet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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Janssen R&D IrelandVoltooid
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Tibotec Pharmaceuticals, IrelandBeëindigd
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Janssen Research & Development, LLCVoltooidHivItalië, Thailand, Spanje, Oeganda, Portugal, Zuid-Afrika
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Tibotec Pharmaceuticals, IrelandVoltooidHiv | Leverfunctiestoornis | AIDS
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Tibotec Pharmaceuticals, IrelandVoltooidFarmacokinetiek | Biologische beschikbaarheid | Hiv-1