Drug Interaction Study With Proton Pump Inhibitor | NCT00357240

Studies
Drug Interaction Study With Proton Pump Inhibitor

NCT00357240

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Apr 8, 2011Estimated

Enrollment

Phase

Phase 1

Conditions

HIV Infections

Interventions

Atazanavir
Atazanavir/Ritonavir
Atazanavir/Ritonavir+Omeprazole
Atazanavir/Ritonavir+Omeprazole
Atazanavir
Atazanavir/Ritonavir
Atazanavir/Ritonavir+Omeprazole
Atazanavir/Ritonavir+Omeprazole

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Jul 25, 2006

First Submission Date that Met QC Criteria

Jul 26, 2006

First Posted Date

Jul 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2011

Last Update Posted Date

Apr 8, 2011Estimated

Description Module

Brief Summary

The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A1	Active Comparator	Drug: Atazanavir
A2	Active Comparator	Drug: Atazanavir/Ritonavir
A3 I	Experimental	Drug: Atazanavir/Ritonavir+Omeprazole
A3 II	Experimental	Drug: Atazanavir/Ritonavir+Omeprazole
B1	Active Comparator	Drug: Atazanavir
B2	Active Comparator	Drug: Atazanavir/Ritonavir
B3 I	Experimental	Drug: Atazanavir/Ritonavir+Omeprazole
B3 II	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atazanavir	Drug	Capsules, Oral, 400 mg, once daily, 6 days.	A1	Reyataz

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.

Secondary Outcomes

Measure	Description	Time Frame
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects between the ages of 18 to 50 years old with BMI 18 to 32 kg/m2

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Hamilton	New Jersey		United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069446	Atazanavir Sulfate
C000718687	atazanavir, ritonavir drug combination

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009842	Oligopeptides

Browse Leaves

Not provided

Browse Branches

Not provided