Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805

NCT01424540 | Completed Phase 1

• 1 other identifier: 115535
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

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

  Echocardiographic measures of contractility

  10 hours

Secondary Outcomes (14)

• 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

• Number of subjects using concurrent medication

  24 hours

• Number of subjects with laboratory values out of range

  24 hours

Study Arms (2)

Treatment A

EXPERIMENTAL

GSK2336805 150mg

Drug: GSK2336805 150mg

Treatment B

PLACEBO COMPARATOR

GSK2336805 Placebo

Other: Placebo

Interventions

GSK2336805 150mg DRUG

Single Dose

Treatment A

Placebo OTHER

Single Dose

Treatment B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Publications (1)

• Wilfret DA, Adkison KK, Jones LA, Lou Y, Gan J, Spreen W. Echocardiogram study to evaluate the effect of the novel hepatitis C virus NS5A inhibitor GSK2336805 on cardiac contractility in healthy subjects. Antimicrob Agents Chemother. 2013 Oct;57(10):5141-3. doi: 10.1128/AAC.00668-13. Epub 2013 Jul 15.

  PMID: 23856771 DERIVED

Related Links

• Results for study 115535 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Hepatitis C

Interventions

GSK2336805

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2011
• First Posted: August 29, 2011
• Study Start: September 1, 2011
• Primary Completion: October 3, 2011
• Study Completion: October 3, 2011
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)