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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272973

U1111-1118-0257 (Other Identifier)

NN9924-3692

2010-019951-23 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 4 patient groups

Oral 1

Experimental group

Treatment:

Drug: placebo

Drug: semaglutide

Drug: semaglutide

Oral 2

Experimental group

Treatment:

Drug: placebo

Drug: semaglutide

Drug: semaglutide

Oral 3

Experimental group

Treatment:

Drug: placebo

Drug: semaglutide

Drug: semaglutide

S.c.

Active Comparator group

Treatment:

Drug: semaglutide

Drug: semaglutide