Healthy VolunteersPhase 1NCT00707538
A Phase I Study in Healthy Volunteers to Assess Dosimetry and Safety Following Injection of BMS747158 at Stress
A Phase 1 study testing BMS747158 in people with Healthy Volunteers, run by Lantheus Medical Imaging at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS747158
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Hopkins University
Baltimore, Maryland, 21287
UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography
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
- Conditions
- Healthy Volunteers
- Being tested
- BMS747158
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS747158Drug
2 IV injection of ~11 mCi (total) F-18 labeled compound
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: BMS747158 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry analysis following whole body imaging after stress injection
Measured: Imaging takes place approximately 0 - 300 minutes post injection
Secondary outcomes (1)
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
Measured: Screening (14 days prior to dosing) through 14 days post dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamshid Maddahi, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707538
- Sponsor's protocol ID
- BMS747158-102
- Status last verified
- Aug 2011
- First submitted
- 27 Jun 2008
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dosimetry, Biodistribution and Safety Study of BMS747158 in Healthy Subjects Undergoing 2-Day Rest/Stress Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT00707538
- Acronym / sponsor ID
- BMS747158-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BMS747158 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Significant active or chronic illness
- Any neurological disorder
- GI disease within 3 months
- Recent infection
- Major surgery within 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS7471582 IV injection of ~11 mCi (total) F-18 labeled compound | Drug | 1 |
Primary outcome
Dosimetry analysis following whole body imaging after stress injection
Time frame: Imaging takes place approximately 0 - 300 minutes post injection
1 secondary outcome
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
Time frame: Screening (14 days prior to dosing) through 14 days post dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamshid Maddahi, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS747158 in people with Healthy Volunteers, run by Lantheus Medical Imaging at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosimetry analysis following whole body imaging after stress injection (time frame: Imaging takes place approximately 0 - 300 minutes post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.