NCT01195974
Terminated
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- YASMIN
- Conditions
- Infection, Human Immunodeficiency Virus
- Sponsor
- ViiV Healthcare
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- AUC of Drospirenone and Ethinyl Estradiol after YASMIN alone and after YASMIN with GSK2248761.
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Investigators
Eligibility Criteria
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.
Arms & Interventions
Period 1
YASMIN + 200 mg GSK2248761 or Placebo
Intervention: YASMIN
Period 1
YASMIN + 200 mg GSK2248761 or Placebo
Intervention: GSK2248761
Period 1
YASMIN + 200 mg GSK2248761 or Placebo
Intervention: Placebo
Period 2
YASMIN + 200 mg GSK2248761 or Placebo
Intervention: YASMIN
Period 2
YASMIN + 200 mg GSK2248761 or Placebo
Intervention: GSK2248761
Period 2
YASMIN + 200 mg GSK2248761 or Placebo
Intervention: Placebo
Run In Period
YASMIN
Intervention: YASMIN
Outcomes
Primary Outcomes
AUC of Drospirenone and Ethinyl Estradiol after YASMIN alone and after YASMIN with GSK2248761.
Time Frame: 21 days
Secondary Outcomes
- Safety and tolerability of all treatments as assessed by 12 lead electrocardiograms, vital signs, adverse events, and clinical laboratory tests.(two months)
- Predose serum levels of progesterone from Periods 1 and 2(21 days)
- 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(21 days)
- Predose serum levels of Luteinizing Hormone and Follicle-Stimulating Hormone from Periods 1 and 2(21 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Comparison of Two Formulations of Proellex for Vaginal AdministrationComparison of 2 Different Formulations of 12 mg Proellex Vaginal CapsulesNCT01962805Repros Therapeutics Inc.8
Completed
Phase 1
Comparison of Two Formulations of Proellex for Oral AdministrationHealthyNCT02141061Repros Therapeutics Inc.12
Completed
Phase 2
Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary HyperhidrosisHyperhidrosisNCT02563899GlaxoSmithKline28
Completed
Phase 1
Multiple Ascending Dose Study of CTP-692 in Healthy VolunteersHealthyNCT03880253Concert Pharmaceuticals30
Completed
Phase 1
Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of VilaprisanClinical Trial, Phase INCT02262663Bayer70