Back to resultsA Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2, Healthy
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
NN9925 (oral)
NN9925 (i.v.)
placebo
NN9925 (oral)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Male subjects with good general health as judged by the physician
- Body weight of 65-95 kg (both inclusive)
- Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)
Exclusion Criteria:
- Known or suspected allergy to trial product or related products
- Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Trial part 1
Trial part 2
Arm Description
Outcomes
Primary Outcome Measures
Number and severity of adverse events (AEs) recorded
Secondary Outcome Measures
The uptake in blood of oral NN9925
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01087645
Brief Title
A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
Official Title
Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 12, 2010 (Actual)
Primary Completion Date
September 16, 2010 (Actual)
Study Completion Date
September 16, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial part 1
Arm Type
Experimental
Arm Title
Trial part 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NN9925 (oral)
Intervention Description
Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation
Intervention Type
Drug
Intervention Name(s)
NN9925 (i.v.)
Intervention Description
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
Intervention Type
Drug
Intervention Name(s)
NN9925 (oral)
Intervention Description
Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will be randomised to receive a single dose of placebo
Primary Outcome Measure Information:
Title
Number and severity of adverse events (AEs) recorded
Time Frame
from dosing to Day 22
Secondary Outcome Measure Information:
Title
The uptake in blood of oral NN9925
Time Frame
from 0 to 504 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male subjects with good general health as judged by the physician
Body weight of 65-95 kg (both inclusive)
Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)
Exclusion Criteria:
Known or suspected allergy to trial product or related products
Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician
Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
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