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Completed

NCT Number: NCT01967589

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.

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Key information

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Harrow, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male, 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
  • Age 18-64 years (both inclusive) at the time of signing informed consent
  • BMI (body mass index) 20.0-29.9 kg/m^2 (both inclusive)

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
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
  • Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy

Treatment and study plan

NNC0113-0987

Drug

Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation

Placebo

Drug

Once-daily doses for oral administration

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs) recorded

    Time frame: From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)

Secondary outcomes

  1. Area under the NNC0113-0987 plasma concentration curve

    Time frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)

  2. Maximum observed NNC0113-0987 plasma concentration

    Time frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)

  3. Time to maximum observed NNC0113-0987 plasma concentration

    Time frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)

  4. Change in fasting plasma glucose (FPG)

    Time frame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)

  5. Change in HbA1C (glycosylated haemoglobin)

    Time frame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)

  6. Change in body weight

    Time frame: From baseline (Day -1) to after 10 weeks of treatment (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
Oct 23, 2013
Registry last updated
Jun 20, 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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