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A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087645
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE March 12, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date February 28, 2017
Actual Study Start Date  ICMJE March 12, 2010
Actual Primary Completion Date September 16, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2010)
Number and severity of adverse events (AEs) recorded [ Time Frame: from dosing to Day 22 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
Severity of adverse events [ Time Frame: from dosing to Day 22 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
The uptake in blood of oral NN9925 [ Time Frame: from 0 to 504 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
Official Title  ICMJE Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
Brief Summary 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 NN9925 in healthy male subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy
Intervention  ICMJE
  • Drug: NN9925 (oral)
    Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation
  • Drug: NN9925 (i.v.)
    As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
  • Drug: placebo
    Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
  • Drug: NN9925 (oral)
    Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1
  • Drug: placebo
    Subjects will be randomised to receive a single dose of placebo
Study Arms  ICMJE
  • Experimental: Trial part 1
    Interventions:
    • Drug: NN9925 (oral)
    • Drug: placebo
  • Experimental: Trial part 2
    Interventions:
    • Drug: NN9925 (i.v.)
    • Drug: NN9925 (oral)
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2010)
70
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2010)
145
Actual Study Completion Date  ICMJE September 16, 2010
Actual Primary Completion Date September 16, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects with good general health as judged by the physician
  • Body weight of 65-95 kg (both inclusive)
  • Body Mass Index (BMI) of 18.5-27.5 kg/m2 (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 physician
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087645
Other Study ID Numbers  ICMJE NN9925-3779
2009-016975-31 ( EudraCT Number )
U1111-1113-2537 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date February 2017

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