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Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272973
First Posted: January 10, 2011
Last Update Posted: February 23, 2015
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Healthy Drug: semaglutide Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 96
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral 1 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.
Experimental: Oral 2 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.
Experimental: Oral 3 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.
Active Comparator: S.c. Drug: semaglutide
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
Other Name: NN9924

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01272973


Locations
Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272973     History of Changes
Other Study ID Numbers: NN9924-3692
U1111-1118-0257 ( Other Identifier: Who )
2010-019951-23 ( EudraCT Number )
First Submitted: January 7, 2011
First Posted: January 10, 2011
Last Update Posted: February 23, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases