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Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
Registration Number
NCT01619345
Lead Sponsor
Novo Nordisk A/S
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
27
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Period 1: NN9924 with 50 mL watersemaglutide-
Period 2: NN9924 with 240 mL watersemaglutide-
Primary Outcome Measures
NameTimeMethod
Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)Assessed 0-4 hours post dose
Secondary Outcome Measures
NameTimeMethod
Area under the NN9924 concentration curveFrom time 0-24 hours
Anatomical location of initial tablet erosion (ITE)Assessed 0-4 hours post dose
Time to ITEAssessed 0-4 hours post dose
Time to CTEAssessed 0-4 hours post dose
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