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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 1

Conditions

HIV Infection
Infection, Human Immunodeficiency Virus

Treatments

Drug: GSK364735 oral solution and oral tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00386347
GRZ108532

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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