| Trial ID: | L3697 |
| Source ID: | NCT03061981
|
| Associated Drug: |
Placebo
|
| Title: |
A Study To Evaluate The Safety,Tolerability, PK and PD Of DA-1241 In Healthy Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Placebo|DRUG: Metformin|DRUG: DA-1241
|
| Outcome Measures: |
Primary: [Safety and Tolerability] 12-lead ECGs, Vital signs. Physical examinations, Clinical laboratory testing and Adverse event assessments, Through study completion, an average of 40 days for each treatment period | Secondary: Maximum concentration of DA-1241 (Cmax), Through the treatment period; 72 hours|Time of maximum plasma DA-1241 concentration (Tmax), Through the treatment period; 72 hours|Area under the concentration-time curve (AUC), Through the treatment period; 72 hours|Apparent terminal elimination half-life (t½), Through the treatment period; 72 hours|Apparent total systemic clearance after oral administration (CL/F), Through the treatment period; 72 hours|Apparent volume of distribution (Vz/F), Through the treatment period; 72 hours|Amount of DA-1241 excreted unchanged in the urine in each collection interval(Ae), Through the treatment period; 72 hours|Cumulative amount of DA-1241 excreted unchanged in the urine (Cum Ae), Through the treatment period; 72 hours|Percentage fraction of DA-1241 excreted unchanged in the urine in each collection interval(Fe), Through the treatment period; 72 hours|Cumulative percentage fraction of DA-1241 excreted unchanged in the urine (Cum Fe), Through the treatment period; 72 hours|Renal clearance (CLR), Through the treatment period; 72 hours | Other: Key metabolites of DA-1241 in Cohort 6, Blood samples and urine samples taken for PK (or PD) analysis will be used. Metabolites to be measured are not determined yet., Through the treatment period; 264 hours
|
| Sponsor/Collaborators: |
Sponsor: Dong-A ST Co., Ltd.
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-03-29
|
| Completion Date: |
2017-10-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-11-20
|
| Locations: |
Early Phase Clinical Unit, Baltimore, Maryland, 21225, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03061981
|
