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

NCT01405261 | Completed Phase 1

• 3 other identifiers: NN9926-3894U1111-1119-15602011-000297-57
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Outcome Measures

Primary Outcomes (1)

• Overview of Treatment Emergent Adverse Events (AEs)

  Up to 25 days after trial product administration

Secondary Outcomes (5)

• Frequency of hypoglycaemic episodes

  From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)

• AUC0-240h; area under the NNC 0113-0987 concentration-time curve

  From time 0 to 240 hours after a single oral or intravenous (i.v.) dose

• AUC, area under the curve

  From time 0 to infinity after a single oral or i.v. dose

• Cmax; maximum concentration of NNC 0113-0987 in plasma

  After a single oral or i.v. dose

• The time to maximum concentration (tmax) of NNC 0113-0987 in plasma

  After a single oral dose

Study Arms (3)

NNC 0113-0987 (gastro)

EXPERIMENTAL

Drug: oral NNC 0113-0987; Drug: oral placebo

NNC 0113-987 (coated)

EXPERIMENTAL

Drug: oral NNC 0113-0987; Drug: oral placebo

NNC 0113-987 (i.v)

EXPERIMENTAL

Drug: I.v. NNC 0113-0987

Interventions

oral NNC 0113-0987 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.

NNC 0113-0987 (gastro)

I.v. NNC 0113-0987 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.

NNC 0113-987 (i.v)

oral placebo DRUG

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

NNC 0113-0987 (gastro); NNC 0113-987 (coated)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Nottingham, NG11 6JS, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 29, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

GB (1)