A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
3 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2010
CompletedStudy Start
First participant enrolled
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2010
CompletedFebruary 28, 2017
February 1, 2017
6 months
March 12, 2010
February 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number and severity of adverse events (AEs) recorded
from dosing to Day 22
Secondary Outcomes (1)
The uptake in blood of oral NN9925
from 0 to 504 hours
Study Arms (2)
Trial part 1
EXPERIMENTALTrial part 2
EXPERIMENTALInterventions
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
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Nottingham, NG11 6JS, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 16, 2010
Study Start
March 12, 2010
Primary Completion
September 16, 2010
Study Completion
September 16, 2010
Last Updated
February 28, 2017
Record last verified: 2017-02