Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects

NCT03144271 | Completed Phase 1

• 3 other identifiers: NN9535-18202007-000303-15U1111-1193-6996
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability of ascending single s.c. doses of NNC 0113-0217 in healthy male subjects, aiming at establishing the Maximum Tolerated Dose (MTD)

Conditions

Diabetes; Diabetes Mellitus, Type 2; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  After 24-33 days

Secondary Outcomes (5)

• Area under the curve of NNC 0113-0217

  From 0-48 hours after dosing

• Area under the curve of NNC 0113-0217

  From 0-168 hours after dosing

• Morning fasting plasma glucose

  At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)

• Morning fasting insulin

  At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)

• Morning fasting glucagon

  At visit 1 (days -28 to -1), 2 (days 0-8), 3 (days 11-13) and 4 (days 17-19)

Study Arms (2)

NNC 0113-0217

EXPERIMENTAL

Dose-escalation trial

Drug: semaglutide

Placebo

PLACEBO COMPARATOR

Dose-escalation trial

Drug: Placebo

Interventions

semaglutide DRUG

A single dose of 0.625, 1.25, 2.5, 5, 10, 20, 40 or 80 μg/kg semaglutide will be administered subcutaneously (s.c. under the skin).

Also known as: NNC 0113-0217

NNC 0113-0217

Placebo DRUG

A single dose of placebo will be administered subcutaneously (s.c. under the skin)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
• Subject is male
• Age 18-65 years, both included
• Body Mass Index (BMI) below 35.0 kg/m\^2 (Body weight between 50 kg -150 kg, both inclusive)
• Good general health based on medical history, physical examination including ECG (Electrocardiogram) and laboratory analysis, as judged by the investigator

You may not qualify if:

• Previous participation, defined as randomised, in any other clinical trial involving this or other investigational products within the last 3 months before dosing
• Patients with MI (Myocardia-Infarction) during the last 12 month
• Patients receiving ACE (Angiotensin-Converting Enzyme) inhibitors, beta-blockers, thiazide diuretics, thyroid hormones, and/or lipid lowering medication who are not on a stable dose for more than 6 weeks prior to start of the study
• Use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine)
• Clinically significant GI (Gastro-Intestinal) disease including inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia, apparent diabetic gastro paresis, diabetic diarrhoea, or surgery of the gastro-intestinal tract (except appendectomy and cholecystectomy)
• Subjects who are sexually active and have not been surgically sterilised must be informed that they and their partner use a highly effective method of contraception (Pearl Index below 1%) such as implants, injectables, combined oral contraceptives, or hormonal IUDs (intrauterine devices), or refrain from sexual intercourse during the study and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by study medication
• Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers, and MAO (Mono-Amino-Oxidase) inhibitors
• Subjects who drink more than 8 cups of tea/coffee per day
• History of drug or alcohol abuse (defined as intake of more than 28 units weekly - 1 unit = 12 oz or 360 ml of beer; 5 oz ir 150 ml of wine; 1.5 oz or 45 ml of distilled spirits)
• Alcohol intake within 48 hours prior to dosing
• Evidence of drug abuse on urine testing and serum at study entry
• The subject smokes 7 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the dosing day and during the confinement period
• Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV-positive
• Impaired hepatic function measured as ALAT (Alanine aminotransferase), ASAT (Aspartate aminotransferase), alkaline phosphatase above three times the upper reference limit (one retest within one week is permitted, the last result being conclusive)
• Clinical significant abnormal laboratory test results during the screening as judged by the Investigator

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

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: May 4, 2017
• First Posted: May 8, 2017
• Study Start: June 11, 2007
• Primary Completion: October 8, 2007
• Study Completion: October 8, 2007
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)