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Safety of NNC 0123-0000-0338 in Healthy Subjects

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01334034
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
5.2
Actual Duration (Months)
13.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: NNC 0123-0000-0338
  • Drug: placebo
  • Drug: insulin glargine
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0123-0000-0338 in Healthy Subjects
Actual Study Start Date :
Apr 11, 2011
Actual Primary Completion Date :
Sep 16, 2011
Actual Study Completion Date :
Sep 16, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Number of adverse events [from trial product administration and until completion of the dosing visit (Day 0 to Day 6)]

Secondary Outcome Measures

  1. Area under the serum insulin concentration-time curve [from 0 to 120 hours after a single dose]

  2. Area under the glucose infusion rate-time curve [from 0 to 24 hours after a single dose]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Neuss Germany 41460

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01334034
Other Study ID Numbers:
  • NN1953-3832
  • U1111-1118-2525
  • 2010-023885-38
First Posted:
Apr 12, 2011
Last Update Posted:
Mar 1, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Insulin Glargine

Study Results

No Results Posted as of Mar 1, 2017