A Randomized, Double Blind, Single Dose, Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805 in Healthy Adult Volunteers

GlaxoSmithKline1 site in 1 country20 target enrollmentSeptember 1, 2011

ConditionsHepatitis C

InterventionsGSK2336805 150mg Placebo

DrugsGSK2336805 150mg

Overview

Phase: Phase 1
Intervention: GSK2336805 150mg
Conditions: Hepatitis C
Sponsor: GlaxoSmithKline
Enrollment: 20
Locations: 1
Primary Endpoint: Number of subjects with a change in ejection fraction greater than 10 percent
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, randomized, two part, double-blind, crossover study in healthy adult subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function comparing with placebo using echocardiography as a primary assessment modality

Registry

clinicaltrials.gov

Start Date

September 1, 2011

End Date

October 3, 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin less than or equal to 1.5xUpper Limit of Normal (ULN).
•Healthy as determined by a responsible and experienced physician, based on a medical evaluation including \[medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
•Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
•A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, oophorectomy, or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
•Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
•Body weight greater than or equal to 50 kilogram (kg) for men and 45 kg for women. Body mass index (BMI) between 18.5-30 inclusive will be allowed.
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•Subject has demonstrated an adequate echocardiographic window.
•QTcB less than 450 milliseconds (msec).

Exclusion Criteria

•A positive pre-study Hepatitis B surface antigen,positive Hepatitis C antibody, or a positive test for HIV antibody result within 3 months of screening.
•Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•A positive pre-study drug/alcohol screen.
•History of regular alcohol consumption within 6 months of the study.
•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).
•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 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.
•Where participation in the study would result in donation of blood or blood products in excess of 500 mililiters within a 56 day period.
•Pregnant females as determined by positive \[serum or urine\] hCG test at screening or prior to dosing.
•Lactating females.

Arms & Interventions

Treatment A

GSK2336805 150mg

Intervention: GSK2336805 150mg

Treatment B

GSK2336805 Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with a change in ejection fraction greater than 10 percent

Time Frame: 10 hours

Echocardiographic measures of contractility

Secondary Outcomes

Correlation between concentration and various safety parameters(24 hours)
Area under the curve (0-24)(24 hours)
Concentration at 24 hours(24 hours)
Troponin lab results(24 hours)
Terminal phase half-life(24 hours)
Lag time before observation of drug concentrations in sampled matrix(24 hours)
Number of subjects using concurrent medication(24 hours)
Number of subjects with laboratory values out of range(24 hours)
Maximum observed concentration (Cmax)(24 hours)
Time of occurrence of Cmax(24 hours)
B-type natriuretic peptide (BNP) lab result(24 hours)
Number of subjects with electrocardiogram (ECG) parameters out of range(3 hours)
Number of subjects with vital signs out of range(24 hours)
Number of subjects with adverse events(24 hours)