A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects
|ClinicalTrials.gov Identifier: NCT01037582|
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2 Healthy||Drug: NN9924 (oral) Drug: placebo Drug: NN9924 (s.c.) Drug: NN9924 (i.v.)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||155 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects|
|Actual Study Start Date :||December 17, 2009|
|Actual Primary Completion Date :||May 7, 2010|
|Actual Study Completion Date :||May 7, 2010|
|Experimental: Trial part 1||
Drug: NN9924 (oral)
Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation.
Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.
|Experimental: Trial part 2||
Drug: NN9924 (oral)
Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.
Subjects will be randomized to receive a single dose of placebo.
Drug: NN9924 (s.c.)
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit
Drug: NN9924 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.
- Number and severity of adverse events (AEs) recorded [ Time Frame: from dosing to Day 22 ]
- The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound [ Time Frame: from 0 to 504 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037582
|Novo Nordisk Investigational Site|
|Harrow, United Kingdom, HA1 3UJ|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|