Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ketoconazole

Criteria

Inclusion Criteria:

• Healthy adults aged 18-60yrs, with BMI of 19-31kg/m2.

• Females must be of non-childbearing potential.

• Subjects must be able to give consent and comply with restrictions of study.

Exclusion Criteria:

• Clinically relevant abnormality from history, physical, 12-lead ECG, Holter monitoring, or clinical laboratory examination.

• Positive urine drug screen.

• Positive urine test for alcohol.

• Contine levels indicative of smoking.

• Positive HIV or Hep B and/or C assay.

• History or smoking in last year or >10 pack/year history of smoking overall.

• History of regular alcohol consumption (7 units/week for women and 14 units/week for men) within 6 months of study.

• History of drug abuse within 6 months of study.

• Participation in another drug trial within 30 days of first dose.

• Exposure to more than 4 new chemical entities within 12 months of first dose.

• Use of prescription and non-prescription drugs including dietary supplements, herbals and St. John's wort within 14 days of first dose.

• Consumption of red wine, grapefruit, grapefruit juice and grapefruit products within 14 days of first dose.

• Donation of blood in excess of 500 mL within 56 days of dosing.

• Evidence of renal, hepatic or biliary impairment.

• History of serious gastrointestinal disease or history of gastrointestinal surgical procedure that might affect absorption of study drug.

• History of sensitivity to any of the study medications.

• History of clinically significant cardiovascular disease.

• History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones. Medical conditions which might alter bone metabolism.

• Liver function tests above ULN at screening and PTH, glucose, and CPK outside the reference range at screening.

• Males unwilling to refrain from fathering a child during the study and for 14 days following the last dose of study medication.