DDI Study of Etravirine and GSK1265744

Healthy Subjects Clinical Trial

Official title:

A Phase I, Open Label Crossover Study to Evaluate the Effect of Etravirine on GSK1265744 Pharmacokinetics in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920296
• Other study ID #: 111839
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2009
• Last updated: August 30, 2010
• Start date: July 2009
• Est. completion date: September 2009

Study information

• Verified date: August 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare steady-state plasma PK, safety and tolerability of GSK1265744 with and without etravirine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.

• Male or female between 18 and 50 years of age.

• A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant).

• Male subjects must agree to use one of the contraception methods listed in the protocol.

• Body weight >=50 kg for men and >=45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

• The subject has a positive pre-study drug/alcohol screen.

• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

• History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.

• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.

• History of regular alcohol consumption within 6 months of the study.

• Has a history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.

• Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.

• Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing.

• Lactating females.

• Unwillingness or inability to follow the procedures outlined in the protocol.

• Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded.

• History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease.

• History/evidence of clinically significant pulmonary disease.

• History of significant renal or hepatic diseases.

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.

• A positive test for HIV antibody.

• Serum creatinine values greater than the upper limit of normal. Serum ALT, ,AST, alkaline phosphatase or bilirubin > 1.5x upper limit of normal.

• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.

• The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.

• Exclusion criteria for screening ECG

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Healthy Subjects
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• GSK1265744
GSK drug

Locations

Country	Name	City	State
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters of GSK1265744		24 days	No
Secondary	PK parameters of etravirine		24 days	No
Secondary	clinical laboratory assessmetns, vital signs, ECGs		24 days	Yes