A Study To Evaluate Formulations And Food Effect On GSK36... | NCT00386347

Studies
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.

NCT00386347

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jun 4, 2012Estimated

Enrollment

Phase

Phase 1

Conditions

HIV Infection
Infection, Human Immunodeficiency Virus

Interventions

GSK364735 oral solution and oral tablets

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

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 6, 2006

First Submission Date that Met QC Criteria

Oct 6, 2006

First Posted Date

Oct 11, 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

May 31, 2012

Last Update Posted Date

Jun 4, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.

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

Name	Type	Description	Arm Group Labels	Other Names
GSK364735 oral solution and oral tablets	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax

Secondary Outcomes

Measure	Description	Time Frame
Part 1 and 2 safety measures: AE, Clinical labs, con meds, ECGs, and Vital signs Part 1: PK parameters Day 1: tmax, t1/2, tlag and CL/F Part 2: PK parameters Day 1&6: AUC 0-t, AUC 0-infinity, AUC 0-12, Cmax, C12 or C24, tmax, t1/2, CL/F, and tlag.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

The subject is healthy with no clinically significant problems identified by the physician.
Females of non-childbearing potential and males surgically sterile or agrees to birth control.
Body mass Index (BMI) of 19-29.9 (kg/m2).

Exclusion criteria:

As a result of the physical examination, lab results the Investigator considers the subject unfit for the study.
Blood pressure and electrocardiogram is not normal
A history of alcohol or illicit drug abuse.
Tobacco use within 3 months.
Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody.
Current use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
Has participated in a clinical trial within 30 days prior to the first dose of study medication.
Donated a pint of blood within a 56 day period.
History of allergy to study drug.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Evansville	Indiana	47714	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D007239	Infections
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases

Browse Leaves

Not provided

Browse Branches

Not provided