Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01424540
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: GSK2336805 150mg Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Single Dose, Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805 in Healthy Adult Volunteers
Actual Study Start Date : September 1, 2011
Actual Primary Completion Date : October 3, 2011
Actual Study Completion Date : October 3, 2011

Arm Intervention/treatment
Experimental: Treatment A
GSK2336805 150mg
Drug: GSK2336805 150mg
Single Dose

Placebo Comparator: Treatment B
GSK2336805 Placebo
Other: Placebo
Single Dose

Primary Outcome Measures :
  1. Number of subjects with a change in ejection fraction greater than 10 percent [ Time Frame: 10 hours ]
    Echocardiographic measures of contractility

Secondary Outcome Measures :
  1. Number of subjects with electrocardiogram (ECG) parameters out of range [ Time Frame: 3 hours ]
    Cardiovascular measures

  2. Number of subjects with vital signs out of range [ Time Frame: 24 hours ]
    Cardiovascular measures

  3. Number of subjects with adverse events [ Time Frame: 24 hours ]

  4. Number of subjects using concurrent medication [ Time Frame: 24 hours ]
    Concomitant medications

  5. Number of subjects with laboratory values out of range [ Time Frame: 24 hours ]

  6. Area under the curve (0-24) [ Time Frame: 24 hours ]
    PK parameter

  7. Maximum observed concentration (Cmax) [ Time Frame: 24 hours ]
    PK parameter

  8. Terminal phase half-life [ Time Frame: 24 hours ]
    PK parameter

  9. Lag time before observation of drug concentrations in sampled matrix [ Time Frame: 24 hours ]
    PK parameter

  10. Time of occurrence of Cmax [ Time Frame: 24 hours ]
    PK parameter

  11. Concentration at 24 hours [ Time Frame: 24 hours ]
    PK parameter

  12. Correlation between concentration and various safety parameters [ Time Frame: 24 hours ]
    Safety, PK

  13. B-type natriuretic peptide (BNP) lab result [ Time Frame: 24 hours ]
    Cardiac biomarkers

  14. Troponin lab results [ Time Frame: 24 hours ]
    Cardiac biomarkers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Subjects who have asthma or a history of asthma.
  • Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication.
  • Left ventricular ejection fraction less than 55% at screening.
  • The subject's systolic blood pressure is outside the range of 90-140, or diastolic blood pressure is outside the range of 45-90 or heart rate is outside the range of 50-100beats per minute for female subjects or 45-100 beats per minute for male subjects.
  • Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination):

Males-Heart rate less than 45 and greater than 100 beats per minute (bpm). Females-Heart rate less than 50 and greater than 100 bpm Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).

Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome). Sinus Pauses greater than 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject. Non-sustained or sustained ventricular tachycardia ( greater than or equal to 3 consecutive ventricular ectopic beats).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01424540

United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT01424540     History of Changes
Other Study ID Numbers: 115535
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases