Phase I Study of SB-480848(Darapladib) -Repeat Dose Study in Healthy Japanese Male Subjects-

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study is being conducted to provide safety, tolerability, PK and PD data in repeat dosing that will allow further studies with darapladib in Japanese patients

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Darapladib

Criteria

Inclusion criteria:

• Healthy Japanese adult males between 20 and 64 yeas of age, inclusive.

• Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.

• Bodyweight >50 kg and body mass index (BMI) between 18.5 and 25.0 at screening.

• Subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

• Baseline QTc interval <450 msec.

• Non-smoker or ex-smoker having ceased smoking for at least 6 months.

• Clinical laboratory examination (AST, ALT, ALP and GGT) at screening are within the normal range.

• The subject is able to attend all visits and complete the study.

Exclusion criteria:

• Any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.

• History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.

• Positive for urine drug at screening.

• Positive for syphilis, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody at screening.

• Use of prescription or no-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

• Consumption of grapefruit juice or food within 7 days prior to the first dose of study medication.

• A history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology.

• Donation of blood in excess of 400mL within 4 months or 200mL within 1 months prior to at screening.

• History of drug abuse, or current conditions of drug abuse or alcoholism.

• Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication.

• Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.

• History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.

• The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.

• History of sensitivity to heparin or heparin-induced thrombocytopenia.