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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01037582
First received: December 21, 2009
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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
Diabetes Mellitus, Type 2
Healthy
Drug: NN9924 (oral)
Drug: placebo
Drug: NN9924 (s.c.)
Drug: NN9924 (i.v.)
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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01037582

Locations
United Kingdom
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Monika Malm-Erjefält, PhD Novo Nordisk A/S
Study Director: Pernille Poulsen, MD 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: NCT01037582     History of Changes
Other Study ID Numbers: NN9924-3691, 2009-012366-31, U1111-1112-7564
Study First Received: December 21, 2009
Last Updated: May 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 16, 2014