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This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders:
GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
Full description
Protocol Number: SSAT069
EudraCT Number: 2015-004799-30
Name of Investigational Product: Microgynon 30®; Evotaz®
Name of active ingredients: Ethinylestradiol, levonorgestrel; atazanavir, cobicistat
Study title: The effect of atazanavir/cobicistat on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel (Microgynon 30®) in healthy women
Phase of study: Phase I
Objectives: The objectives of this study are:
Primary
-To assess the pharmacokinetics of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary
Study design: 57 days (excluding screening and follow up), open label, cross-over, pharmacokinetic study
Indication: Not applicable
Methodology: Measurements of steady state pharmacokinetic profiles of plasma ethinylestradiol/levonorgestrel and atazanavir/cobicistat
Planned sample size: Up to 30 female healthy volunteers will be enrolled at baseline in order to achieve 18 completing the study
Summary of eligibility criteria: Healthy female participants as determined by medical history, physical examination, 12-lead electrocardiogram, and clinical laboratory evaluations will be eligible to participate in the study. Women of childbearing potential must not be nursing or pregnant. Women of childbearing potential must have a negative pregnancy test at screening.
Number of study centres: One
Duration of treatment: 57 days (excluding screening and follow up visits)
Dose and route of administration: All participants will be administered Microgynon 30® (ethinylestradiol/levonorgestrel 30 micrograms/150 micrograms) and Evotaz® (atazanavir 300 mg/cobicistat 150 mg) as follows:
GROUP 1:
Microgynon 30® for 21 days Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Evotaz® for 14 days
GROUP 2:
Evotaz® for 14 days followed by 7 days wash-out Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack)
Criteria for evaluation: Pharmacokinetic parameters of ethinylestradiol/levonorgestrel and atazanavir/cobicistat will be evaluated on blood drawn on day 14, 35 and 56 at 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24 hours post dose
Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.
Primary Endpoint: Steady state plasma concentrations of ethinylestradiol/levonorgestrel and atazanavir/cobicistat during co-administration in HIV negative female healthy volunteers
Secondary End point: Safety and tolerability of the studied drugs during co-administration
Relationship between genetic polymorphisms and exposure to the studied drugs
Enrollment
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Inclusion criteria
Participants must meet all of the following inclusion criteria within 28 days prior to the baseline visit:
The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
Non-pregnant, non-lactating females.
Between 18 to 35 years, inclusive
Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive
ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination.
Women of childbearing potential (WOCBP) must be using an additional adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 4 weeks after the study (these include only the ones listed below, as no other hormone-based contraception is allowed during the study)
A female may be eligible to enter and participate in the study if she:
is of non-child-bearing potential defined as physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
is of child-bearing potential with a reliable negative pregnancy test at both Screening and Day 1 with no risk in between and agrees to use one of the following methods of contraception to avoid pregnancy from screening, throughout the study, and for at least 4 weeks after discontinuation of all study medications:
Any contraception method must be used consistently, in accordance with the approved product label and for at least four weeks after discontinuation of IMP.
Willing to consent to their personal details being entered onto the TOPS database
Willing to provide proof of identity by photographic ID at screen and any subsequent visit
Registered with a GP in the UK
Exclusion criteria
Participants who meet any of the following exclusion criteria are not to be enrolled in this study.
Primary purpose
Allocation
Interventional model
Masking
13 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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