A Phase I Study in Healthy Volunteers to Assess Dosimetry... | NCT00707538

Studies
A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress

NCT00707538

Sponsor

Lantheus Medical Imaging

Status

Completed

Last Update Posted

Nov 10, 2020Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

BMS747158

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jun 27, 2008

First Submission Date that Met QC Criteria

Jun 30, 2008

First Posted Date

Jul 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2020

Last Update Posted Date

Nov 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this clinical research study is to learn the biodistribution of injection of BMS747158 at stress and assess the safety of two doses of BMS747158

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: BMS747158

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS747158	Drug	2 IV injection of ~11 mCi (total) F-18 labeled compound	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dosimetry analysis following whole body imaging after stress injection		Imaging takes place approximately 0 - 300 minutes post injection

Secondary Outcomes

Measure	Description	Time Frame
Safety analysis following vital signs, ECGs, EEG, neuro and physical exams, telephone and visit follow up, and blood draws for chemistry and hematology post injection of BMS747158 at rest and stress		Screening (14 days prior to dosing) through 14 days post dose administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-40
BMI 18-30 kg/m2
No active or chronic illnesses
If female: not pregnant, use of birth control or not of child-bearing potential

Exclusion Criteria:

Significant active or chronic illness
Any neurological disorder
GI disease within 3 months
Recent infection
Major surgery within 4 weeks
Donation of blood within 4 weeks
Blood transfusion within 4 weeks
Recent history drug/alcohol abuse
Head trauma
Significant screening ECG, EEG, lab tests, physical exam and vital signs abnormalities
Prescription or OTC drugs within 2 weeks
Exposure to any other investigational

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jamshid Maddahi, MD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Medical Center		Los Angeles	California	90095	United States
John Hopkins University

Intervention Browse Module

MeSH Terms

ID	Term
C525920	BMS 747158-02

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided