Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

Healthy Clinical Trial

Official title:

Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866748
• Other study ID #: NN9928-4048
• Secondary ID: 2012-003199-38U1
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2013
• Last updated: April 25, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator

• Body Mass Index (BMI) between 20 and 30 kg/m^2

• Glycosylated haemoglobin (HbA1c) below 6.0% (only in Part B)

Exclusion Criteria:

• History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator

• Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. Occasional use of paracetamol or acetylsalicylic acid is permitted

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• semaglutide
A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.
• semaglutide
Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts.
• placebo
In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.
• placebo
In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of treatment emergent adverse events (TEAEs)		Day -1 to Day 24	No
Primary	Part B: Number of treatment emergent adverse events (TEAEs)		Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104)	No
Secondary	Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve		From time 0 to 24 hours after a single dose (Day 0)	No
Secondary	Part B: AUCt,semaglutide: area under the semaglutide plasma concentration curve		Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)	No
Secondary	Part B: Change in fasting plasma glucose (FPG) from baseline		Day 0 (pre-dose), day 70	No
Secondary	Part B: Change in body weight from baseline		Day -1, day 70	No

External Links

•   Clinical Trials at Novo Nordisk