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Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 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: NCT01272973
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 7, 2011
First Posted Date  ICMJE January 10, 2011
Last Update Posted Date February 23, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
Frequency of adverse events (AEs) [ Time Frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2011)
  • Hypoglycaemic episodes [ Time Frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose ]
  • Laboratory safety variables (haematology, biochemistry, and urinalysis) [ Time Frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose ]
  • Maximum plasma concentration of NN9924 [ Time Frame: after dosing on the 68th, 69th and 70th Day ]
  • Area under the plasma concentration curve over the dosing interval (0-24 hours) [ Time Frame: after dosing on the 68th, 69th and 70th day ]
  • Terminal phase elimination half-life [ Time Frame: from last dose (day 70) to follow-up visit 91-105 days after first dose ]
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 Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
Official Title  ICMJE Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects
Brief Summary This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 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: semaglutide
    Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
  • Drug: placebo
    Placebo (oral) administered once daily for 10 weeks.
  • Drug: semaglutide
    Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
    Other Name: NN9924
Study Arms  ICMJE
  • Experimental: Oral 1
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Experimental: Oral 2
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Experimental: Oral 3
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Active Comparator: S.c.
    Intervention: Drug: semaglutide
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: January 7, 2011)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects, based on an assessment of medical history, physical examination and
  • BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion Criteria:

  • Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
  • Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
  • The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01272973
Other Study ID Numbers  ICMJE NN9924-3692
U1111-1118-0257 ( Other Identifier: Who )
2010-019951-23 ( EudraCT Number )
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 2015

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