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Completed

NCT Number: NCT01272973

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 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–60 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

  • Healthy male subjects, based on an assessment of medical history, physical examination and
  • BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion criteria

  • Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
  • Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
  • The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial

Treatment and study plan

semaglutide

Drug

Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.

Placebo

Drug

Placebo (oral) administered once daily for 10 weeks.

Primary outcomes

  1. Frequency of adverse events (AEs)

    Time frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

Secondary outcomes

  1. Hypoglycaemic episodes

    Time frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

  2. Laboratory safety variables (haematology, biochemistry, and urinalysis)

    Time frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose

  3. Maximum plasma concentration of NN9924

    Time frame: after dosing on the 68th, 69th and 70th Day

  4. Area under the plasma concentration curve over the dosing interval (0-24 hours)

    Time frame: after dosing on the 68th, 69th and 70th day

  5. Terminal phase elimination half-life

    Time frame: from last dose (day 70) to follow-up visit 91-105 days after first dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2011
Registry last updated
Feb 23, 2015

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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