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Completed

NCT Number: NCT01619345

Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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.

Other names: NN9924

Primary outcomes

  1. Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)

    Time frame: Assessed 0-4 hours post dose

Secondary outcomes

  1. Area under the NN9924 concentration curve

    Time frame: From time 0-24 hours

  2. Anatomical location of initial tablet erosion (ITE)

    Time frame: Assessed 0-4 hours post dose

  3. Time to ITE

    Time frame: Assessed 0-4 hours post dose

  4. Time to CTE

    Time frame: Assessed 0-4 hours post dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2012
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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