Status:
COMPLETED
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokine...
Eligibility Criteria
Inclusion
- Body mass index 18.0-28.0 kg/m\^2
- Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion
- Known or suspected hypersensitivity to trial products or related products
- Previous participation in this trial. Participation is defined as randomised
- Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
- Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Key Trial Info
Start Date :
March 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2013
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01809184
Start Date
March 4 2013
End Date
September 6 2013
Last Update
March 1 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Neuss, Germany, 41460