NCT00393328

Brief Summary

The purpose of this clinical research study is to assess the bioequivalence of atazanavir administered as a single 300 mg capsule relative to two atazanavir 150 mg capsules in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

April 8, 2011

Status Verified

June 1, 2008

Enrollment Period

1 month

First QC Date

October 23, 2006

Last Update Submit

April 7, 2011

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Blood atazanavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study

Secondary Outcomes (2)

  • Blood ritonavir pharmacokinetic sampling to be collected on days 1, 2 and 3 of each of the 2 periods of the study

  • Safety parameters including physical exam (PE), vital signs (VS), electrocardiogram (ECG) and clinical laboratory tests will be collected at study discharge

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Atazanavir + Ritonavir

B

ACTIVE COMPARATOR
Drug: Atazanavir + Ritonavir

Interventions

Atazanavir + RitonavirDRUG

Capsules, Oral, ATV 300mg as 2-150mg + RTV 100mg, single dose, 7 days washout crossed over to Treatment B.

Also known as: Abilify
A

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 30 kg/m²
  • Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Hamilton, New Jersey, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

atazanavir, ritonavir drug combinationAripiprazole

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 27, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

April 8, 2011

Record last verified: 2008-06

Locations

US(1)