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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2, Healthy

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

semaglutide

placebo

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part A (single dose)

Part B (multiple dose)

Arm Description

Outcomes

Primary Outcome Measures

Part A: Number of treatment emergent adverse events (TEAEs)

Part B: Number of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve

Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve

Part B: Change in fasting plasma glucose (FPG) from baseline

Part B: Change in body weight from baseline

Full Information

NCT ID

NCT01866748

First Posted

May 22, 2013

Last Updated

April 25, 2014

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01866748

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A (single dose)

Arm Type

Experimental

Arm Title

Part B (multiple dose)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

semaglutide

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

semaglutide

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention 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).

Primary Outcome Measure Information:

Title

Part A: Number of treatment emergent adverse events (TEAEs)

Time Frame

Day -1 to Day 24

Title

Part B: Number of treatment emergent adverse events (TEAEs)

Time Frame

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 Information:

Title

Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve

Time Frame

From time 0 to 24 hours after a single dose (Day 0)

Title

Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve

Time Frame

Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69)

Title

Part B: Change in fasting plasma glucose (FPG) from baseline

Time Frame

Day 0 (pre-dose), day 70

Title

Part B: Change in body weight from baseline

Time Frame

Day -1, day 70

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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