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

NCT ID: NCT00468689

Last Updated: 2008-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-08-31

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.

Conditions

Osteoporosis

Keywords

SB-751689,; Calcium-sensing receptor antagonist (CaR),; Osteoporosis,; Parathyroid hormone (PTH),; Oral dose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

SB-751689 oral tablets (100 and 400 ng)

Intervention Type: DRUG

Ketoconazole (NIZORAL) oral tablets (200 mg)

Intervention Type: DRUG

Other Intervention Names

SB-751689 oral tablets (100 and 400 ng)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

CR9107262

Identifier Type: -

Identifier Source: org_study_id