Clinical Trial Details
| Trial ID: | L0616 |
| Source ID: | NCT00888069 |
| Associated Drug: | Ctap101 Capsules |
| Title: | Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Secondary Hyperparathyroidism|Chronic Renal Insufficiency|Chronic Renal Failure |
| Interventions: | DRUG: CTAP101 Capsules|DRUG: CTAP101 Injection |
| Outcome Measures: | Primary: To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT, from 3 to 0 hours prior to dosing until 42 days post dosing | Secondary: To assess the safety and tolerability of CTAP101 capsules and injection, From signing of ICF (Day -35) through study completion (Day 42 post dosing)|To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT., From signing of ICF (Day -35) through study completion (Day 42 post dosing) |
| Sponsor/Collaborators: | Sponsor: OPKO IP Holdings II, Inc. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 28 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2009-05 |
| Completion Date: | 2009-12 |
| Results First Posted: | |
| Last Update Posted: | 2014-09-30 |
| Locations: | Pivotal Research Centers, Peoria, Arizona, 85381, United States|Research by Design, Evergreen Park, Illinois, 60805, United States|Western New England Renal & Transplant Associates, Springfield, Massachusetts, 01107, United States|Twin Cities Clinical Research, Brooklyn Center, Minnesota, 55430, United States|DCI, Cincinnati, Ohio, 45206, United States|MetroHealth Medical Center, Cleveland, Ohio, 44109-1998, United States|Northeast Clinical Research, Allentown, Pennsylvania, 18103, United States|Southeast Renal Research Institute, Chattanooga, Tennessee, 37404, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Southwest Houston Research Ltd, Houston, Texas, 77099, United States|Purity Dialysis Centers / Nephrology Associates, Delafield, Wisconsin, 53018, United States|Gunderson Clinic Ltd., La Crosse, Wisconsin, 54601, United States |
| URL: | https://clinicaltrials.gov/show/NCT00888069 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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