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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: December 21, 2009
Last updated: February 23, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: NN9924 (oral)
Drug: placebo
Drug: NN9924 (s.c.)
Drug: NN9924 (i.v.)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects

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

Primary Outcome Measures:
  • Number and severity of adverse events (AEs) recorded [ Time Frame: from dosing to Day 22 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 155
Actual Study Start Date: December 17, 2009
Study Completion Date: May 7, 2010
Primary Completion Date: May 7, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trial part 1 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.
Experimental: Trial part 2 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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01037582

United Kingdom
Novo Nordisk Investigational Site
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01037582     History of Changes
Other Study ID Numbers: NN9924-3691
2009-012366-31 ( EudraCT Number )
U1111-1112-7564 ( Other Identifier: WHO )
Study First Received: December 21, 2009
Last Updated: February 23, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 24, 2017