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Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01619345
Enrollment
27
Registered
2012-06-14
Start date
2012-06-30
Completion date
2012-08-31
Last updated
2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGsemaglutide

Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)Assessed 0-4 hours post dose

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026