A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: NN9924 (oral); Drug: NN9924 (i.v.); Drug: placebo; Drug: NN9924 (s.c.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037582

2009-012366-31 (EudraCT Number)

U1111-1112-7564 (Other Identifier)

NN9924-3691

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy male subjects.

Enrollment: 155 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male subjects with good general health as judged by the Investigator
• Body weight of 65.0-95.0 kg (both inclusive)
• Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (both inclusive)

Exclusion criteria

• Known or suspected allergy to trial product or related products
• Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the Investigator
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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155 participants in 2 patient groups

Trial part 1

Experimental group

Treatment:

Drug: placebo

Drug: NN9924 (oral)

Drug: placebo

Drug: NN9924 (oral)

Trial part 2

Experimental group

Treatment:

Drug: placebo

Drug: NN9924 (s.c.)

Drug: NN9924 (oral)

Drug: placebo

Drug: NN9924 (i.v.)

Drug: NN9924 (oral)