| Trial ID: | L5604 |
| Source ID: | NCT02106585
|
| Associated Drug: |
Jtt-251 Or Placebo
|
| Title: |
Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: JTT-251 or Placebo
|
| Outcome Measures: |
Primary: Number of subjects with adverse events, 1 week|Vital signs and 12 lead ECGs, 1 week|Cmax (maximum concentration), 1 week|t1/2 (elimination half-life), 1 week|AUC (area under the concentration-time curve), 1 week|fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval), 1 week |
|
| Sponsor/Collaborators: |
Sponsor: Akros Pharma Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
94
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-03
|
| Completion Date: |
2014-08
|
| Results First Posted: |
|
| Last Update Posted: |
2014-10-07
|
| Locations: |
Orlando, Florida, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02106585
|