A Phase 1 Trial to Determine Dosimetry, Biodistribution a... | NCT00891241

Studies
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure

NCT00891241

Sponsor

Lantheus Medical Imaging

Status

Completed

Last Update Posted

Nov 16, 2020Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Heart Failure

Interventions

LMI 1195-101

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

Nov 2020

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

Aug 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 29, 2009

First Submission Date that Met QC Criteria

Apr 30, 2009

First Posted Date

May 1, 2009Estimated

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 12, 2020

Last Update Posted Date

Nov 16, 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 study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)

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
Cohort 1	Experimental	Healthy Population	Drug: LMI 1195-101
Cohort 2	Experimental	Heart Failure Subjects with a documented ejection fraction of 35% or less, and a diagnosis of NYHA Class II-III heart failure, history of ventricular arrhythmia and ICD placement	Drug: LMI 1195-101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LMI 1195-101	Drug	Single dose, bolus IV injection of LMI 1195	Cohort 1 Cohort 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of LMI 1195 in terms of treatment-related adverse events	Number of study subjects exhibiting treatment-related adverse events	14 days

Secondary Outcomes

Measure	Description	Time Frame
Radiation Dosimetry of a single dose of LMI 1195	Radiation dose to organs defined by the MIRD model, in mGy/MBq	2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Cohort 1 Inclusion:

Healthy, age 18-40

Cohort 1 Exclusion:

Significant or chronic medical illness
Pregnant females
Smoking within one month of enrollment
Use of any prescription drugs within 4 weeks prior to dosing

Cohort 2 Inclusion:

30-70 year old subjects with a diagnosis of NYHA Class II-III heart failure
Ejection fraction less than or equal to 35%
Rest SPECT imaging within 90 days prior to enrollment

Cohort 2 Exclusion:

Significant or chronic medical illness
Pregnant females
Known history of arrhythmogenic disorder or rhythm disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
L. Veronica Lee, M.D.	Medical Monitor - Lantheus Medical Imaging	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hartford Hospital		Hartford	Connecticut	06102	United States
Yale University Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided