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Completed

NCT Number: NCT01866748

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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.

Placebo

Drug

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

Primary outcomes

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

    Time frame: Day -1 to Day 24

  2. 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 outcomes

  1. 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)

  2. 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)

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

    Time frame: Day 0 (pre-dose), day 70

  4. Part B: Change in body weight from baseline

    Time frame: Day -1, day 70

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 31, 2013
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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