Safety of NNC 0123-0000-0338 in Healthy Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: placebo

Drug: insulin glargine

Drug: NNC 0123-0000-0338

Study type

Interventional

Funder types

Industry

Identifiers

NCT01334034

NN1953-3832

U1111-1118-2525 (Other Identifier)

2010-023885-38 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.

Enrollment

70 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male subject
Body mass index (BMI) between 18 and 28 kg/m^2 (both inclusive)

Exclusion criteria

Known or suspected hypersensitivity to trial products or related products
Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician