Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT01031199

First received: December 11, 2009

Last updated: March 31, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 11, 2009

Last Updated Date

March 31, 2013

Start Date ^ICMJE

January 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Standard quantification variables derived from 3D PET imaging and brain modeling. [ Time Frame: Day of study tracer administration ] [ Designated as safety issue: No ]
Visual analysis/description of the uptake and description of brain PET scans. [ Time Frame: Day of study tracer administration ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01031199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Standard Safety Parameter: Adverse Event Collection [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]
Standard Safety Parameter: Electrocardiogram [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]
Standard Safety Parameter: Safety laboratory [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]
Standard Safety Parameter: Vital signs [ Time Frame: maximum time from Screening to Follow-up are 37days ] [ Designated as safety issue: Yes ]

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

Evaluation of the Positron Emission Tomography (PET) Tracer ZK 6032924 in Patients With Multiple Sclerosis Compared to Healthy Volunteers

Official Title ^ICMJE

Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 140 MBq (ca. 5 mSv) ZK 6032924 (BAY85-8101) for Its Diagnostic Potential in Either Drug-naïve or Specifically (IFN-beta) Pretreated Patients With Multiple Sclerosis (MS) With Acute Relapse or Patients With Clinically Isolated Syndrome (CIS), Compared to Healthy Volunteers

Brief Summary

PET (positron emission tomography) imaging with BAY85-8101 for investigation in patients with Multiple Sclerosis compared to healthy volunteers

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Positron-Emission Tomography
Multiple Sclerosis

Intervention ^ICMJE

Drug: F-18 FEDAA1106 (BAY85-8101)
MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET
Drug: F-18 FEDAA1106 (BAY85-8101)
Healthy controls: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer < 5 µg, PET

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: F-18 FEDAA1106 (BAY85-8101)
Experimental: Arm 2
Intervention: Drug: F-18 FEDAA1106 (BAY85-8101)

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

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy volunteers for brain imaging:

males or females, age 20 - 55 years
assessment of the brain MRI as "normal (age-appropriate)"
absence of any sign of CNS disease, no co-medi cation Patients for brain imaging
males or females, age 20 - 55 years
patients with previously diagnosed MS, presenting with acute relapse, without any current immunomodulating therapy for MS ("drug-naïve"), or patients presenting with first clinical episode suggestive of demyelinating disease (Clinically Isolated Syndrome, CIS)
patients with previously diagnosed MS, presenting with acute relapse, receiving currently immunomodulatory therapy exclusively with interferon β
MRI: >/= 2 T2 lesions and >/= 1 Gadolinium- (Gd-) enhancing lesion

Exclusion Criteria:

Exclusion criteria for all healthy volunteers and patients:

Pregnancy or lactation
Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
other forms of diseases with neuroinflammatory components

Gender

Both

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01031199

Other Study ID Numbers ^ICMJE

13101, 2008-000981-22

Has Data Monitoring Committee

Responsible Party

Head Clinical Pharmacology, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

April 2013

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

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