Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

NCT01690169 | Completed Phase 1

• 3 other identifiers: NN9927-39092012-000047-27U1111-1126-7584
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

Secondary Outcomes (4)

• Number and severity of hypoglycaemic episodes

  From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

• AUC, the area under the NNC0113-0987 plasma concentration-time curve

  From dosing visit to infinity

• Cmax, the maximum plasma concentration of NNC0113-0987

  From dosing visit until last PK sampling visit (e.g. day 11)

• tmax, the time to maximum plasma concentration of NNC0113-0987

  From dosing visit until last PK sampling visit (e.g. day 11)

Study Arms (2)

NNC0113-0987

EXPERIMENTAL

Drug: NNC0113-0987

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC0113-0987 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.

NNC0113-0987

placebo DRUG

A single dose of oral placebo administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• 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 assessments at the screening visit
• Body mass index (BMI) above or equal to 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 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 21, 2012
• Study Start: September 14, 2012
• Primary Completion: December 11, 2012
• Study Completion: December 11, 2012
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

GB (1)