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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: SB-751689 oral tablets (100 and 400 ng)

Drug: Ketoconazole (NIZORAL) oral tablets (200 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00468689

CR9107262

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.