Safety of NNC 0123-0000-0338 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01334034
First received: April 11, 2011
Last updated: September 28, 2011
Last verified: September 2011
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.


Condition Intervention Phase
Diabetes
Healthy
Drug: NNC 0123-0000-0338
Drug: placebo
Drug: insulin glargine
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: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0123-0000-0338 in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: from trial product administration and until completion of the dosing visit (Day 0 to Day 6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the serum insulin concentration-time curve [ Time Frame: from 0 to 120 hours after a single dose ] [ Designated as safety issue: No ]
  • Area under the glucose infusion rate-time curve [ Time Frame: from 0 to 24 hours after a single dose ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: April 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose levels 1-7 Drug: NNC 0123-0000-0338
Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.
Drug: placebo
Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.
Drug: insulin glargine
As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subject
  • Body mass index (BMI) between 18 and 28 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial products or related products
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
  • Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician
  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: NCT01334034

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Inge Birk Halberg Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01334034     History of Changes
Other Study ID Numbers: NN1953-3832, U1111-1118-2525, 2010-023885-38
Study First Received: April 11, 2011
Last Updated: September 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)

Additional relevant MeSH terms:
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014