A Study to Evaluate the Effect of Two Different Repeat Doses of GSK2190915 on the QTc Interval.

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, placebo controlled, four way crossover, in which the the effect of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin 400mg (single dose) with a weeks washout prior to starting the next course. Key assessments include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events .

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Male or female between 18 and 65 years of age inclusive

• Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5x Upper limit of normal (ULN)

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

• A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal . Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods. Those of child-bearing potential must agree to use one of the protocol contraception methods.

• Body mass index (BMI) within the range 18.5-29.0 kg/m2 (inclusive)

• Capable of giving written informed consent

• Current non-smokers who have not used tobacco products in the 6 month period preceding screening

• No significant abnormality on 12-lead electrocardiogram (ECG) at screening

• A 24 hour Holter ECG at screening that demonstrates no clinically significant abnormalities

Exclusion Criteria:

• A physician deems the subject unsuitable for the study

• A screening Holter ECG tracing that reveals clinically concerning arrhythmias

• A blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.

• A mean heart rate outside the range 40-90 beats per minute (bpm) at screening.

• History or presence of any medically significant disease, or any disorder. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.

• A positive result for Hepatitis B or Hepatitis C within 3 months of screening

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities

• A positive pre-study drug/alcohol screen

• A positive test for Human Immunodeficiency Virus (HIV) antibody

• 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 3 months of the first dosing day in the current study

• Exposure to more than four new chemical entities within 12 months prior to the first dosing day

• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements from 14 days before screening until the follow-up visit unless permitted by the investigator

• History of sensitivity to any of the study medications

• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 3 month period

• Pregnant females

• Lactating females

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

• Subject is mentally or legally incapacitated