Back to resultsEvaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB-751689 oral tablets (100 and 400 ng)
Ketoconazole (NIZORAL) oral tablets (200 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring SB-751689,, Calcium-sensing receptor antagonist (CaR),, Osteoporosis,, Parathyroid hormone (PTH),, Oral dose
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.
Sites / Locations
- GSK Investigational Site
Outcomes
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468689
Brief Title
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
SB-751689,, Calcium-sensing receptor antagonist (CaR),, Osteoporosis,, Parathyroid hormone (PTH),, Oral dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB-751689 oral tablets (100 and 400 ng)
Intervention Type
Drug
Intervention Name(s)
Ketoconazole (NIZORAL) oral tablets (200 mg)
Other Intervention Name(s)
SB-751689 oral tablets (100 and 400 ng)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
12. IPD Sharing Statement
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Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
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