- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01619345
Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects
February 20, 2015 updated by: Novo Nordisk A/S
Pharmacoscintigraphic Investigation 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nottingham, United Kingdom, NG11 6JS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Period 1: NN9924 with 50 mL water
|
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:
|
Experimental: Period 2: NN9924 with 240 mL water
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)
Time Frame: Assessed 0-4 hours post dose
|
Assessed 0-4 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the NN9924 concentration curve
Time Frame: From time 0-24 hours
|
From time 0-24 hours
|
Anatomical location of initial tablet erosion (ITE)
Time Frame: Assessed 0-4 hours post dose
|
Assessed 0-4 hours post dose
|
Time to ITE
Time Frame: Assessed 0-4 hours post dose
|
Assessed 0-4 hours post dose
|
Time to CTE
Time Frame: Assessed 0-4 hours post dose
|
Assessed 0-4 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
June 12, 2012
First Submitted That Met QC Criteria
June 12, 2012
First Posted (Estimate)
June 14, 2012
Study Record Updates
Last Update Posted (Estimate)
February 23, 2015
Last Update Submitted That Met QC Criteria
February 20, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- NN9924-3957
- 2011-004162-14 (EudraCT Number)
- U1111-1123-7450 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on semaglutide
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, India, Japan, Russian Federation, United Kingdom, Canada, Spain, South Africa, Germany, Greece, United Arab Emirates, Argentina, Puerto Rico
-
Novo Nordisk A/SCompletedObesityUnited States, Israel, United Kingdom, Denmark, Germany, Netherlands, Canada, Argentina, Czechia, Hungary, Poland, Spain, Australia
-
Novo Nordisk A/SCompletedObesity | Diabetes Mellitus, Type 2 | OverweightKorea, Republic of, Hong Kong, Brazil, China
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Germany
-
Novo Nordisk A/SCompletedType 2 Diabetes | Healthy VolunteersUnited States, Canada
-
Sansum Diabetes Research InstituteNovo Nordisk A/STerminatedDiabetes Mellitus, Type 2 | Glucose Metabolism Disorders (Including Diabetes Mellitus)United States
-
Novo Nordisk A/SCompletedObesity | OverweightUnited States, Italy, Spain, Canada, Hungary
-
Novo Nordisk A/SCompletedObesity | OverweightJapan, Korea, Republic of
-
Novo Nordisk A/SCompletedOverweight or Obesity | Metabolism and Nutrition DisorderUnited States, India, Mexico, Russian Federation, United Kingdom, Canada, Denmark, Finland, Belgium, Japan, Taiwan, France, Poland, Germany, Bulgaria, Argentina, Puerto Rico