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Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Healthy
Diabetes

Treatments

Drug: semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01619345
U1111-1123-7450 (Other Identifier)
NN9924-3957
2011-004162-14 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.

Enrollment

27 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Good general health
  • Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)

Exclusion criteria

  • Males who are not willing to use two acceptable forms of highly effective contraception
  • Participation in another clinical trial within 90 days
  • Any chronic disorder or severe disease
  • Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing
  • Subjects who are smokers
  • Subjects who have donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Period 1: NN9924 with 50 mL water
Experimental group
Treatment:
Drug: semaglutide
Period 2: NN9924 with 240 mL water
Experimental group
Treatment:
Drug: semaglutide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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