Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

Healthy Clinical Trial

Official title:

Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619345
• Other study ID #: NN9924-3957
• Secondary ID: 2011-004162-14U1
• Status: Completed
• Phase: Phase 1
• First received: June 12, 2012
• Last updated: February 20, 2015
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: February 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• semaglutide
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)		Assessed 0-4 hours post dose	No
Secondary	Area under the NN9924 concentration curve		From time 0-24 hours	No
Secondary	Anatomical location of initial tablet erosion (ITE)		Assessed 0-4 hours post dose	No
Secondary	Time to ITE		Assessed 0-4 hours post dose	No
Secondary	Time to CTE		Assessed 0-4 hours post dose	No

External Links

•   Clinical Trials at Novo Nordisk