Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
Phase 1
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2Healthy
- Interventions
- Drug: placebo
- Registration Number
- NCT01272973
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 96
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral 1 placebo - Oral 2 placebo - Oral 3 placebo - Oral 2 semaglutide - Oral 3 semaglutide - Oral 1 semaglutide - S.c. semaglutide -
- Primary Outcome Measures
Name Time Method Frequency of adverse events (AEs) 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 Outcome Measures
Name Time Method Terminal phase elimination half-life from last dose (day 70) to follow-up visit 91-105 days after first dose Laboratory safety variables (haematology, biochemistry, and urinalysis) from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose Maximum plasma concentration of NN9924 after dosing on the 68th, 69th and 70th Day Hypoglycaemic episodes from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose Area under the plasma concentration curve over the dosing interval (0-24 hours) after dosing on the 68th, 69th and 70th day