ClinicalTrials.Veeva

Menu

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

Novo Nordisk logo

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

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems