Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-08 @ 3:30 AM
Study NCT ID:
NCT02589158
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2015-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat
Sponsor:
St Stephens Aids Trust
Organization:
Study Overview
Official Title:
Steady-state Pharmacokinetics of Atazanavir/Cobicistat and Darunavir/Cobicistat Once Daily Over 72 Hours in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to look at the levels of three HIV medications: atazanavir, darunavir and cobicistat in the blood after drug intake has been stopped, in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 10 days. Participants will take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and cobicistat) on a second stage.
If the participants decide to take part, the duration of the study will be up to 33 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order.
The participant and the study doctor will know which study medications the participant is taking at all times during the study.
If the participants decide to take part, the duration of the study will be up to 33 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order.
The participant and the study doctor will know which study medications the participant is taking at all times during the study.
Detailed Description:
Protocol Number: SSAT067
EudraCT Number: 2015-002956-28
Name of Investigational Product: Evotaz®, Rezolsta®
Name of active ingredients: Atazanavir, darunavir and cobicistat
Study title: Steady-state Pharmacokinetics of Atazanavir/Cobicistat and Darunavir/Cobicistat Once Daily Over 72 Hours in Healthy Volunteers
Phase of study: Phase I
Objectives:
Primary:
-To assess the steady-state pharmacokinetics of atazanavir/cobicistat and darunavir/cobicistat over 72 hours, in HIV negative healthy volunteers.
Secondary:
* To assess the inter subject variability in atazanavir, darunavir and cobicistat plasma concentrations over 72 hours
* To assess the safety and tolerability of atazanavir/cobicistat and darunavir/cobicistat over 10 days of administration to healthy volunteers
* To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Study design: 33 days (excluding screening and follow up), open label, pharmacokinetic study.
Indication: Not applicable
Methodology: Measurements of steady state pharmacokinetic profiles of plasma atazanavir/cobicistat and darunavir/cobicistat in male and female healthy volunteers.
Planned sample size: Up to 30 male and female healthy volunteers will be enrolled at baseline in order to achieve 16 completing the study
Summary of eligibility criteria: Healthy 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: 33 days (excluding screening and follow up visits)
Dose and route of administration: All participants will be administered Evotaz®) (atazanavir 300mg + cobicistat 150mg) once daily for 10 days, undergo a ten-day wash out period and then take Rezolsta® (darunavir 800mg + cobicistat 150mg) once daily for 10 days.
Criteria for evaluation:
* Pharmacokinetic parameters of atazanavir/cobicistat will be evaluated on blood drawn on day 10 at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post dose and days 11 to 13 (up to 72 hours post dose).
* Pharmacokinetic parameters of darunavir/cobicistat will be evaluated on blood drawn on day 30 at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post dose and days 31 to 33 (up to 72 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 atazanavir/cobicistat and darunavir/cobicistat up to 72 hours post-dose.
Secondary End point:
* Safety and tolerability of the studied drugs over 10 days of administration.
* Relationship between genetic polymorphisms and exposure to the studied drugs.
EudraCT Number: 2015-002956-28
Name of Investigational Product: Evotaz®, Rezolsta®
Name of active ingredients: Atazanavir, darunavir and cobicistat
Study title: Steady-state Pharmacokinetics of Atazanavir/Cobicistat and Darunavir/Cobicistat Once Daily Over 72 Hours in Healthy Volunteers
Phase of study: Phase I
Objectives:
Primary:
-To assess the steady-state pharmacokinetics of atazanavir/cobicistat and darunavir/cobicistat over 72 hours, in HIV negative healthy volunteers.
Secondary:
* To assess the inter subject variability in atazanavir, darunavir and cobicistat plasma concentrations over 72 hours
* To assess the safety and tolerability of atazanavir/cobicistat and darunavir/cobicistat over 10 days of administration to healthy volunteers
* To investigate the association between genetic polymorphisms in drug disposition genes and drug exposure
Study design: 33 days (excluding screening and follow up), open label, pharmacokinetic study.
Indication: Not applicable
Methodology: Measurements of steady state pharmacokinetic profiles of plasma atazanavir/cobicistat and darunavir/cobicistat in male and female healthy volunteers.
Planned sample size: Up to 30 male and female healthy volunteers will be enrolled at baseline in order to achieve 16 completing the study
Summary of eligibility criteria: Healthy 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: 33 days (excluding screening and follow up visits)
Dose and route of administration: All participants will be administered Evotaz®) (atazanavir 300mg + cobicistat 150mg) once daily for 10 days, undergo a ten-day wash out period and then take Rezolsta® (darunavir 800mg + cobicistat 150mg) once daily for 10 days.
Criteria for evaluation:
* Pharmacokinetic parameters of atazanavir/cobicistat will be evaluated on blood drawn on day 10 at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post dose and days 11 to 13 (up to 72 hours post dose).
* Pharmacokinetic parameters of darunavir/cobicistat will be evaluated on blood drawn on day 30 at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post dose and days 31 to 33 (up to 72 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 atazanavir/cobicistat and darunavir/cobicistat up to 72 hours post-dose.
Secondary End point:
* Safety and tolerability of the studied drugs over 10 days of administration.
* Relationship between genetic polymorphisms and exposure to the studied drugs.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: