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NCT01087645 Clinical Trial

A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects

Healthy Clinical Trial

Official title:
Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01087645
Other study ID # NN9925-3779
Secondary ID 2009-016975-31U1
Status Completed
Phase Phase 1
First received March 12, 2010
Last updated February 24, 2017
Start date March 12, 2010
Est. completion date September 16, 2010

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date September 16, 2010
Est. primary completion date September 16, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NN9925 (oral)
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
• NN9925 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
• placebo
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
• NN9925 (oral)
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
• placebo
Subjects will be randomised to receive a single dose of placebo

Locations
Country Name City State
United Kingdom Novo Nordisk Investigational Site Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number and severity of adverse events (AEs) recorded from dosing to Day 22
Secondary The uptake in blood of oral NN9925 from 0 to 504 hours
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