A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: NN9925 (oral); Drug: NN9925 (i.v.); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01087645

NN9925-3779

2009-016975-31 (EudraCT Number)

U1111-1113-2537 (Other Identifier)

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 NN9925 in healthy male subjects.

Enrollment: 70 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 physician
• Body weight of 65-95 kg (both inclusive)
• Body Mass Index (BMI) of 18.5-27.5 kg/m2 (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 physician
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Trial part 1

Experimental group

Treatment:

Drug: NN9925 (oral)

Drug: NN9925 (oral)

Drug: placebo

Drug: placebo

Trial part 2

Experimental group

Treatment:

Drug: NN9925 (oral)

Drug: NN9925 (oral)

Drug: placebo

Drug: placebo

Drug: NN9925 (i.v.)