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Completed

NCT Number: NCT01690169

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male 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 single doses of NNC0113-0987 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

Novo Nordisk Investigational Site

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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 assessments at the screening visit
  • Body mass index (BMI) above or equal to 18.5 and below 30 kg/m^ 2

Exclusion criteria

  • Male subjects who are sexually active and not surgically sterilised, who or whose partner is 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 12 weeks following the last dose of trial medication
  • Participation in another trial within 90 days prior to screening
  • Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an 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 acute idiopathic or chronic pancreatitis

Treatment and study plan

NNC0113-0987

Drug

A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.

Placebo

Drug

A single dose of oral placebo administered.

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

Secondary outcomes

  1. Number and severity of hypoglycaemic episodes

    Time frame: From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

  2. AUC, the area under the NNC0113-0987 plasma concentration-time curve

    Time frame: From dosing visit to infinity

  3. Cmax, the maximum plasma concentration of NNC0113-0987

    Time frame: From dosing visit until last PK sampling visit (e.g. day 11)

  4. tmax, the time to maximum plasma concentration of NNC0113-0987

    Time frame: From dosing visit until last PK sampling visit (e.g. day 11)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Feb 28, 2017

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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