A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01037582

First received: December 21, 2009

Last updated: May 23, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2009

Last Updated Date

May 23, 2012

Start Date ^ICMJE

December 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number and severity of adverse events (AEs) recorded [ Time Frame: from dosing to Day 22 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Severity of adverse events [ Time Frame: from dosing to Day 22 ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01037582 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound [ Time Frame: from 0 to 504 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

Official Title ^ICMJE

Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects

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 NN9924 in healthy male subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2
Healthy

Intervention ^ICMJE

Drug: NN9924 (oral)
Subjects will be randomized to receive a single dose of NN9924, 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 NN9924, at all dose levels.
Drug: NN9924 (oral)
Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.
Drug: placebo
Subjects will be randomized to receive a single dose of placebo.
Drug: NN9924 (s.c.)
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit
Drug: NN9924 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.

Study Arm (s)

Experimental: Trial part 1
Interventions:
- Drug: NN9924 (oral)
- Drug: placebo
Experimental: Trial part 2
Interventions:
- Drug: NN9924 (oral)
- Drug: placebo
- Drug: NN9924 (s.c.)
- Drug: NN9924 (i.v.)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

155

Completion Date

May 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male subjects with good general health as judged by the Investigator
Body weight of 65.0-95.0 kg (both inclusive)
Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (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 Investigator
Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01037582

Other Study ID Numbers ^ICMJE

NN9924-3691, 2009-012366-31, U1111-1112-7564

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Monika Malm-Erjefält, PhD	Novo Nordisk
Study Director:	Pernille Poulsen, MD	Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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