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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468689
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : October 13, 2008
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: SB-751689 oral tablets (100 and 400 ng) Drug: Ketoconazole (NIZORAL) oral tablets (200 mg) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Two-Part Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-751689 When Administered as an Oral Formulation at Supratherapeutic Dose Levels in Healthy Adult Subjects.
Study Start Date : April 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Intervention Details:
    Drug: SB-751689 oral tablets (100 and 400 ng) Drug: Ketoconazole (NIZORAL) oral tablets (200 mg)
    Other Name: SB-751689 oral tablets (100 and 400 ng)

Primary Outcome Measures :
  1. 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 [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: throughout the study ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468689

United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00468689     History of Changes
Other Study ID Numbers: CR9107262
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008

Keywords provided by GlaxoSmithKline:
Calcium-sensing receptor antagonist (CaR),
Parathyroid hormone (PTH),
Oral dose

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors