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

Novo Nordisk A/S96 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2 Healthy

Interventions

semaglutideDRUG

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

placeboDRUG

Placebo (oral) administered once daily for 10 weeks.

semaglutideDRUG

Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Berlin, Germany

Outcomes

Primary Outcomes

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

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

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

Maximum plasma concentration of NN9924

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

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

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

Terminal phase elimination half-life

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

Data from ClinicalTrials.gov

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