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A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging

A Phase II Open-Label, Non-Randomized, Single-Center Trial to Determine the Optimal Myocardial Perfusion Image Acquisition Time Following BMS068645 Administration

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00162071
Enrollment
20
Registered
2005-09-13
Start date
2005-07-31
Completion date
Unknown
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Ischemic Heart Disease

Brief summary

The primary purpose of this study is to determine the optimal time for myocardial perfusion imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety of BMS068645 will also be studied.

Interventions

Sponsors

Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age or older * Have known or suspected heart disease * Have undergone a clinically indicated SPECT MPI study with adenosine in the last 24 hours to 14 days. * Weigh between 88 and 250 lbs.

Exclusion criteria

* Allergic reaction to Technetium Tc99m Sestamibi or any of its components * History of asthma or lung disease * Ingestion of caffeinated substances within 12 hours prior to the study

Design outcomes

Primary

MeasureTime frame
Measurements of Technetium Tc99m Sestamibi activity will be obtained from various regions of the body at the end of the study to determine optimal imaging times.

Secondary

MeasureTime frame
A comparison of adverse events will be conducted at the end of the study to assess safety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026