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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief 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.

Overall Status Completed
Start Date May 2013
Completion Date April 2014
Primary Completion Date April 2014
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Part A: Number of treatment emergent adverse events (TEAEs) Day -1 to Day 24
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)
Secondary Outcome
Measure Time Frame
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)
Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)
Part B: Change in fasting plasma glucose (FPG) from baseline Day 0 (pre-dose), day 70
Part B: Change in body weight from baseline Day -1, day 70
Enrollment 170
Condition
Intervention

Intervention Type: Drug

Intervention Name: semaglutide

Description: 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.

Arm Group Label: Part A (single dose)

Intervention Type: Drug

Intervention Name: semaglutide

Description: 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.

Arm Group Label: Part B (multiple dose)

Intervention Type: Drug

Intervention Name: placebo

Description: In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.

Arm Group Label: Part A (single dose)

Intervention Type: Drug

Intervention Name: placebo

Description: 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).

Arm Group Label: Part B (multiple dose)

Eligibility

Criteria:

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 64 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Location Countries

Germany

Verification Date

April 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Part A (single dose)

Type: Experimental

Label: Part B (multiple dose)

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov