| Trial ID: | L3704 |
| Source ID: | NCT01690169
|
| Associated Drug: |
Nnc0113-0987
|
| Title: |
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: NNC0113-0987|DRUG: placebo
|
| Outcome Measures: |
Primary: Number of treatment emergent adverse events (TEAEs), From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25) | Secondary: Number and severity of hypoglycaemic episodes, From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)|AUC, the area under the NNC0113-0987 plasma concentration-time curve, From dosing visit to infinity|Cmax, the maximum plasma concentration of NNC0113-0987, From dosing visit until last PK sampling visit (e.g. day 11)|tmax, the time to maximum plasma concentration of NNC0113-0987, From dosing visit until last PK sampling visit (e.g. day 11)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09-14
|
| Completion Date: |
2012-12-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-28
|
| Locations: |
Novo Nordisk Investigational Site, Nottingham, NG11 6JS, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01690169
|
