MedDataX Logo

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

NCT ID: NCT01405261

Last Updated: 2013-11-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Diabetes Mellitus, Type 2 Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NNC 0113-0987 (gastro)

Group Type EXPERIMENTAL

oral NNC 0113-0987

Intervention Type DRUG

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.

oral placebo

Intervention Type DRUG

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

NNC 0113-987 (coated)

Group Type EXPERIMENTAL

oral NNC 0113-0987

Intervention Type DRUG

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.

oral placebo

Intervention Type DRUG

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

NNC 0113-987 (i.v)

Group Type EXPERIMENTAL

I.v. NNC 0113-0987

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

oral placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 and urinary laboratory assessments at the screening visit
* Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m\^2

Exclusion Criteria

* Male subjects who are sexually active and not surgically sterilised, who or whose partner are 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 3 months following the last dose of trial medication
* The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial
* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have 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 chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nottingham, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1119-1560

Identifier Type: OTHER

Identifier Source: secondary_id

2011-000297-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9926-3894

Identifier Type: -

Identifier Source: org_study_id