Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-14

Study Completion Date

2012-12-11

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 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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NNC0113-0987

Group Type EXPERIMENTAL

NNC0113-0987

Intervention Type DRUG

A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

A single dose of oral placebo administered.

Interventions

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NNC0113-0987

A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.

Intervention Type DRUG

placebo

A single dose of oral placebo administered.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit
* Body mass index (BMI) above or equal to 18.5 and below 30 kg/m\^ 2

Exclusion Criteria

* Male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication
* Participation in another trial within 90 days prior to screening
* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator
* Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
* History of acute idiopathic or chronic pancreatitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes