A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects
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|ClinicalTrials.gov Identifier: NCT01037582|
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : January 3, 2019
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|