Safety of NNC 0123-0000-0338 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-11

Study Completion Date

2011-09-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose levels 1-7

Group Type EXPERIMENTAL

NNC 0123-0000-0338

Intervention Type DRUG

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.

placebo

Intervention Type DRUG

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.

insulin glargine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes