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Completed

NCT Number: NCT01978613

Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.

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Key information

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: No

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 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
  • Body mass index (BMI): 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, 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 syndrome type 2
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
  • Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted

Treatment and study plan

NNC0113-0987

Drug

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

Placebo

Drug

Tablets for one-daily oral administration.

Primary outcomes

  1. Number of treatment emergent adverse events 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. Number of hypoglycaemic episodes

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

  2. Area under the NNC0113-0987 plasma concentration time curve

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

  3. 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)

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
Nov 7, 2013
Registry last updated
Jun 30, 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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