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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: I.v. NNC 0113-0987; Drug: oral placebo; Drug: oral NNC 0113-0987

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405261

2011-000297-57 (EudraCT Number)

U1111-1119-1560 (Other Identifier)

NN9926-3894

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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101 participants in 3 patient groups

NNC 0113-0987 (gastro)

Experimental group

Treatment:

Drug: oral NNC 0113-0987

Drug: oral NNC 0113-0987

Drug: oral placebo

NNC 0113-987 (coated)

Experimental group

Treatment:

Drug: oral NNC 0113-0987

Drug: oral NNC 0113-0987

Drug: oral placebo

NNC 0113-987 (i.v)

Experimental group

Treatment:

Drug: I.v. NNC 0113-0987