| Trial ID: | L4004 |
| Source ID: | NCT02686281
|
| Associated Drug: |
Gmc-252-L-Lysine
|
| Title: |
Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Healthy
|
| Interventions: |
DRUG: GMC-252-L-Lysine|OTHER: Placebo
|
| Outcome Measures: |
Primary: Number of Participants with Serious and Non-Serious Adverse Events, Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry), Over a 14 days period post dose | Secondary: Maximal Concentration (Cmax), Over a 14 days period post dose|Area Under the Concentration-Time Curve, Over a 14 days period post dose
|
| Sponsor/Collaborators: |
Sponsor: Genmedica Therapeutics S.L. | Collaborators: Simbec Research
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
19
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09
|
| Completion Date: |
2014-04
|
| Results First Posted: |
|
| Last Update Posted: |
2016-04-19
|
| Locations: |
Simbec Research Ltd, Merthyr Tydfil, CF48 4DR, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02686281
|
