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

February 24, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

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

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • Novo Nordisk Investigational Site

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trial part 1
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
Drug: placebo
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
Drug: 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
Drug: placebo
Subjects will be randomised to receive a single dose of placebo
Experimental: Trial part 2
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
Drug: placebo
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
Drug: 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
Drug: placebo
Subjects will be randomised to receive a single dose of placebo
Drug: NN9925 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and severity of adverse events (AEs) recorded
Time Frame: from dosing to Day 22
from dosing to Day 22

Secondary Outcome Measures

Outcome Measure
Time Frame
The uptake in blood of oral NN9925
Time Frame: from 0 to 504 hours
from 0 to 504 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

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 (Actual)

March 12, 2010

Primary Completion (Actual)

September 16, 2010

Study Completion (Actual)

September 16, 2010

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9925-3779
  • 2009-016975-31 (EudraCT Number)
  • U1111-1113-2537 (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.

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