A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01037582
First received: December 21, 2009
Last updated: May 23, 2012
Last verified: May 2012

December 21, 2009
May 23, 2012
December 2009
May 2010   (final data collection date for primary outcome measure)
Number and severity of adverse events (AEs) recorded [ Time Frame: from dosing to Day 22 ] [ Designated as safety issue: Yes ]
Severity of adverse events [ Time Frame: from dosing to Day 22 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01037582 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects
Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy male subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
  • 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.
  • Drug: placebo
    Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.
  • 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.
  • Drug: placebo
    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.
  • Experimental: Trial part 1
    Interventions:
    • Drug: NN9924 (oral)
    • Drug: placebo
  • Experimental: Trial part 2
    Interventions:
    • Drug: NN9924 (oral)
    • Drug: placebo
    • Drug: NN9924 (s.c.)
    • Drug: NN9924 (i.v.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male subjects with good general health as judged by the Investigator
  • Body weight of 65.0-95.0 kg (both inclusive)
  • Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the Investigator
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01037582
NN9924-3691, 2009-012366-31, U1111-1112-7564
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Monika Malm-Erjefält, PhD Novo Nordisk A/S
Study Director: Pernille Poulsen, MD Novo Nordisk A/S
Novo Nordisk A/S
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP