GSK618334 Repeat Dose Study

• Status: Completed
• Trial end date: 2010-02-17
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.

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

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Healthy Males and Females between the ages of 18-50 years old

• Male and Female subjects must agree to use protocol specified contraceptive methods.

• Male subjects only in PET parts of the study.

• Capable of providing written informed consent.

Exclusion Criteria:

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

• Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.

• Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).

• Screening ECG parameters outside the protocol specified parameters.

• Pulse rate <50 or >100 bpm OR a systolic blood pressure >140 or <95 mmHg OR a diastolic blood pressure >90 or <50 mmHg at screening and/or baseline.

• Pregnant or lactating females.

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

• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.

• Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.

• Significant suicidal risk.