Pharmacokinetic Effect of Evotaz/Microgynon Co-administration

  • STATUS
    Not Recruiting
  • participants needed
    30
  • sponsor
    St Stephens Aids Trust
Updated on 22 January 2021
body mass index
hysterectomy
cobicistat
direct bilirubin
atazanavir

Summary

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.

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 - To assess the safety and tolerability of ethinylestradiol/levonorgestrel and atazanavir/cobicistat when co-administered to HIV negative female healthy volunteers - To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure 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

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines
Treatment Microgynon 30®, Evotaz®
Clinical Study IdentifierNCT02697851
SponsorSt Stephens Aids Trust
Last Modified on22 January 2021

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