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

Phase 1

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00468689
• Lead Sponsor: GlaxoSmithKline

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 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-01
• Study First Submitted QC: 2007-05-01
• Study First Posted: 2007-05-03
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-09
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests	throughout the study

Secondary Outcome Measures

Name	Time	Method
PK and of SB-751689 as determined by AUC, Cmax, tmax, and half-life. PD effects (PTH, serum Ca) as determined by AUC, Emax, tmax, maximum change and % change from baseline, duration of effect, duration above ULN for PTH.	throughout the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Baltimore, Maryland, United States