- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01195974
A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.
18. februar 2019 oppdatert av: ViiV Healthcare
A Double-Blind Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Drospirenone and Ethinyl Estradiol When Co-administered With GSK2248761 in Healthy Adult Female Subjects
This study is a two-period, double-blind study in healthy adult female subjects.
Each subject will participate in an oral contraceptive Run-in period prior to the treatment periods.
The length of the Run-in Period will be 28 days or longer, depending on the timing of the subject's menstrual cycle and on whether the subject is taking an OC.
Each subject will participate in this run-in period (if needed), followed by two treatment periods.
Treatment Periods 1 and 2 must be conducted successively.
Subjects will be randomized in a cross-over fashion to either YASMIN with GSK2248761 or Placebo for 10 days and switch GSK2248761 or placebo for another 10 days.
Subjects will return to the study center for final follow up evaluations 7 - 14 days after the final dose of study medication.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Studietype
Intervensjonell
Registrering (Faktiske)
13
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Dakota
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Fargo, North Dakota, Forente stater, 58104
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 40 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin greater than 1.5xUpper limit of normal is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
- Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Female, between 18 and 40 years of age inclusive, at the time of signing the informed consent.
- Women of childbearing potential must use the following appropriate contraceptive methods: oral contraceptive YASMIN in combination with complete abstinence from intercourse for at least 14 days prior to the first dose of investigational product (Day 1 of Period 1), throughout the study, and for the subsequent post study monitoring or; YASMIN in combination with a barrier method plus a spermicide (e.g., condom or diaphragm with spermicidal foam/gel/cream/ suppository for at least 14 days prior to the first dose of investigational product [Day 1 of Period 1]) throughout the study, and for the subsequent post study monitoring or; Sterilization (vasectomy) of male partner prior to commencement of female subject's last normal menstrual period prior to administration of study drug, and the male partner is the sole partner for that female subject;
- The subject's Body Mass Index is 19 to 30 killograms/millimeters squared and body weight greater than or equal to 50 kilograms (110 pounds) and less than 114 kilograms (less than 250 pounds);
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Single QTc, QTcB or QTcF less than 450 msec; or QTc less than 480 msec in subjects with Bundle Branch Block
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >7 drinks for females.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mililiters within a 56 day period.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception from at least 14 days prior to the first dose of investigational product until completion of the follow-up visit;
- Pregnant females as determined by positive hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of any condition that would contraindicate OC administration (including hypertension, stroke, ischemic heart disease, venous thromboembolism, carcinoma of the breast, etc.);
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subjects who have asthma or a history of asthma, (e.g., for any FTIH where risk of bronchoconstriction is unknown, or compound specific where risk of bronchoconstriction).
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Period 1
YASMIN + 200 mg GSK2248761 or Placebo
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YASMIN for 21 days
200 mg GSK2248761 taken on Days 1 - 10 or Days 12 - 21
Placebo taken on Days 1 - 10 or Days 12 - 21
|
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Eksperimentell: Period 2
YASMIN + 200 mg GSK2248761 or Placebo
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YASMIN for 21 days
200 mg GSK2248761 taken on Days 1 - 10 or Days 12 - 21
Placebo taken on Days 1 - 10 or Days 12 - 21
|
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Annen: Run In Period
YASMIN
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YASMIN for 21 days
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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AUC of Drospirenone and Ethinyl Estradiol after YASMIN alone and after YASMIN with GSK2248761.
Tidsramme: 21 days
|
21 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Safety and tolerability of all treatments as assessed by 12 lead electrocardiograms, vital signs, adverse events, and clinical laboratory tests.
Tidsramme: two months
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two months
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The maximum observed plasma concentration, the minimum observed plasma concentration, time of occurrence for maximum drug concentration, time of occurrence for minimum drug concentration and the half life of DRSP and EE
Tidsramme: 21 days
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21 days
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Predose serum levels of Luteinizing Hormone and Follicle-Stimulating Hormone from Periods 1 and 2
Tidsramme: 21 days
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21 days
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Predose serum levels of progesterone from Periods 1 and 2
Tidsramme: 21 days
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21 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. september 2010
Primær fullføring (Faktiske)
9. februar 2011
Studiet fullført (Faktiske)
9. februar 2011
Datoer for studieregistrering
Først innsendt
3. september 2010
Først innsendt som oppfylte QC-kriteriene
3. september 2010
Først lagt ut (Anslag)
6. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- RNA-virusinfeksjoner
- Virussykdommer
- Blodbårne infeksjoner
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Sykdomsattributter
- Langsomme virussykdommer
- HIV-infeksjoner
- Infeksjoner
- Smittsomme sykdommer
- Ervervet immunsviktsyndrom
- Fysiologiske effekter av legemidler
- Reproduktive kontrollmidler
- Drospirenon og etinyløstradiol kombinasjon
Andre studie-ID-numre
- 113394
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