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Completed

NCT Number: NCT01405261

Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 in healthy male subjects.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments at the screening visit
  • Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m^2

Exclusion criteria

  • Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
  • The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial
  • Subjects with a 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 that might have impact on the current trial, as judged by the investigator
  • Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
  • History of chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)

Treatment and study plan

oral NNC 0113-0987

Drug

Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.

I.v. NNC 0113-0987

Drug

Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.

oral placebo

Drug

Subjects will be randomised to receive a single dose of placebo.

Primary outcomes

  1. Overview of Treatment Emergent Adverse Events (AEs)

    Time frame: Up to 25 days after trial product administration

Secondary outcomes

  1. Frequency of hypoglycaemic episodes

    Time frame: From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration)

  2. AUC0-240h; area under the NNC 0113-0987 concentration-time curve

    Time frame: From time 0 to 240 hours after a single oral or intravenous (i.v.) dose

  3. AUC, area under the curve

    Time frame: From time 0 to infinity after a single oral or i.v. dose

  4. Cmax; maximum concentration of NNC 0113-0987 in plasma

    Time frame: After a single oral or i.v. dose

  5. The time to maximum concentration (tmax) of NNC 0113-0987 in plasma

    Time frame: After a single oral dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2011
Registry last updated
Nov 28, 2013

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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