| Trial ID: | L0647 |
| Source ID: | NCT01460199
|
| Associated Drug: |
Ctp-499
|
| Title: |
Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Stage 3 Chronic Kidney Disease
|
| Interventions: |
DRUG: CTP-499|DRUG: placebo
|
| Outcome Measures: |
Primary: Safety measures, number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams, 4 weeks | Secondary: Pharmacokinetic Profile, Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC), 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Concert Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
33
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-08
|
| Completion Date: |
2011-12
|
| Results First Posted: |
|
| Last Update Posted: |
2013-05-24
|
| Locations: |
West Coast Clinical Trials, Costa Mesa, California, United States|Southern California Clinical Research, Garden Grove, California, United States|Orange County Research Center, Tustin, California, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01460199
|
