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Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619345
First Posted: June 14, 2012
Last Update Posted: February 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Healthy Drug: semaglutide Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE) [ Time Frame: Assessed 0-4 hours post dose ]

Secondary Outcome Measures:
  • Area under the NN9924 concentration curve [ Time Frame: From time 0-24 hours ]
  • Anatomical location of initial tablet erosion (ITE) [ Time Frame: Assessed 0-4 hours post dose ]
  • Time to ITE [ Time Frame: Assessed 0-4 hours post dose ]
  • Time to CTE [ Time Frame: Assessed 0-4 hours post dose ]

Enrollment: 27
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1: NN9924 with 50 mL water 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.
Other Name: NN9924
Experimental: Period 2: NN9924 with 240 mL water 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.
Other Name: NN9924

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619345


Locations
United Kingdom
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01619345     History of Changes
Other Study ID Numbers: NN9924-3957
2011-004162-14 ( EudraCT Number )
U1111-1123-7450 ( Other Identifier: WHO )
First Submitted: June 12, 2012
First Posted: June 14, 2012
Last Update Posted: February 23, 2015
Last Verified: February 2015