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

Completed · Phase 1

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00468689

Run by

GlaxoSmithKline

People needed

15

Starts

2007-04-01

Expected to finish

2007-08-01

Last updated by the study team

2008-10-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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