Status:
COMPLETED
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoporosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 inhi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00468689
Start Date
April 1 2007
End Date
August 1 2007
Last Update
October 13 2008
Active Locations (1)
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1
GSK Investigational Site
Baltimore, Maryland, United States, 21225