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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01272973
First received: January 7, 2011
Last updated: May 23, 2012
Last verified: May 2012
  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: NN9924
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration of NN9924 [ Time Frame: after dosing on the 68th, 69th and 70th Day ] [ Designated as safety issue: No ]
  • Area under the plasma concentration curve over the dosing interval (0-24 hours) [ Time Frame: after dosing on the 68th, 69th and 70th day ] [ Designated as safety issue: No ]
  • Terminal phase elimination half-life [ Time Frame: from last dose (day 70) to follow-up visit 91-105 days after first dose ] [ Designated as safety issue: No ]

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: NN9924
NN9924 (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: NN9924
NN9924 (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: NN9924
NN9924 (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: NN9924
Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272973

Locations
Germany
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Charlotte Keller Stensberg, Senior Clinical Pharmacologist Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01272973     History of Changes
Other Study ID Numbers: NN9924-3692, U1111-1118-0257, 2010-019951-23
Study First Received: January 7, 2011
Last Updated: May 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)

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

ClinicalTrials.gov processed this record on July 31, 2014