Overview

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Withdrawn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