A Two Part Trial Investigating the Safety of NN9925 in Healthy Male 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

2010-03-12

Study Completion Date

2010-09-16

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2 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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Trial part 1

Group Type EXPERIMENTAL

NN9925 (oral)

Intervention Type DRUG

Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation

placebo

Intervention Type DRUG

Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels

Trial part 2

Group Type EXPERIMENTAL

NN9925 (i.v.)

Intervention Type DRUG

As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit

NN9925 (oral)

Intervention Type DRUG

Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1

placebo

Intervention Type DRUG

Subjects will be randomised to receive a single dose of placebo

Interventions

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NN9925 (oral)

Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation

Intervention Type DRUG

NN9925 (i.v.)

As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit

Intervention Type DRUG

placebo

Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels

Intervention Type DRUG

NN9925 (oral)

Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1

Intervention Type DRUG

placebo

Subjects will be randomised to receive a single dose of placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects with good general health as judged by the physician
* Body weight of 65-95 kg (both inclusive)
* Body Mass Index (BMI) of 18.5-27.5 kg/m2 (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 physician
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes