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Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects

NCT01405261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-11-28

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 in healthy male subjects.

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy

Interventions

DRUG

oral NNC 0113-0987

Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.

DRUG

oral NNC 0113-0987

Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.

DRUG

I.v. NNC 0113-0987

Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.

DRUG

oral placebo

Subjects will be randomised to receive a single dose of placebo.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01405261 on ClinicalTrials.gov