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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00468689 |
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 |
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Osteoporosis |
Drug: SB-751689 oral tablets (100 and 400 ng) Drug: Ketoconazole (NIZORAL) oral tablets (200 mg) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Single Group Assignment, Safety/Efficacy Study |
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. |
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) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CR9107262 |
Study First Received: | May 1, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00468689 History of Changes |
Health Authority: | United States: Food and Drug Administration |
SB-751689, Calcium-sensing receptor antagonist (CaR), Osteoporosis, Parathyroid hormone (PTH), Oral dose |
Calcium, Dietary Musculoskeletal Diseases Clotrimazole Miconazole Antifungal Agents Tioconazole |
Osteoporosis Bone Diseases, Metabolic Healthy Ketoconazole Hormones Bone Diseases |
Anti-Infective Agents Musculoskeletal Diseases Therapeutic Uses Antifungal Agents Osteoporosis |
Bone Diseases, Metabolic Ketoconazole Bone Diseases Pharmacologic Actions |