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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00468689
First received: May 1, 2007
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 15
Study Start Date: April 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB-751689 oral tablets (100 and 400 ng) Drug: Ketoconazole (NIZORAL) oral tablets (200 mg)
    Other Names:
    • SB-751689 oral tablets (100 and 400 ng)
    • Ketoconazole (NIZORAL) oral tablets (200 mg)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468689

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00468689     History of Changes
Other Study ID Numbers: CR9107262
Study First Received: May 1, 2007
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
SB-751689,
Calcium-sensing receptor antagonist (CaR),
Osteoporosis,
Parathyroid hormone (PTH),
Oral dose

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014