| Trial ID: | L6507 |
| Source ID: | NCT01405261
|
| Associated Drug: |
Oral Nnc 0113-0987
|
| Title: |
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2|Healthy
|
| Interventions: |
DRUG: oral NNC 0113-0987|DRUG: oral NNC 0113-0987|DRUG: I.v. NNC 0113-0987|DRUG: oral placebo
|
| Outcome Measures: |
Primary: Overview of Treatment Emergent Adverse Events (AEs), Up to 25 days after trial product administration | Secondary: Frequency of hypoglycaemic episodes, From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)|AUC0-240h; area under the NNC 0113-0987 concentration-time curve, From time 0 to 240 hours after a single oral or intravenous (i.v.) dose|AUC, area under the curve, From time 0 to infinity after a single oral or i.v. dose|Cmax; maximum concentration of NNC 0113-0987 in plasma, After a single oral or i.v. dose|The time to maximum concentration (tmax) of NNC 0113-0987 in plasma, After a single oral dose
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
101
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-08
|
| Completion Date: |
2012-05
|
| Results First Posted: |
|
| Last Update Posted: |
2013-11-28
|
| Locations: |
Nottingham, NG11 6JS, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT01405261
|
