Neurodegenerative DiseasesPhase 1NCT00316797
Biodistribution and Safety of a Radiopharmaceutical in Healthy Subjects
A Phase 1 study testing 123-I INER in people with Neurodegenerative Diseases, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial summary
The initial study of [123I] INER will be completed in two parts. Once Part A (Preliminary whole body biodistribution) is completed, Part B (Serial dynamic SPECT assessment of regional brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and regional distribution and washout counts… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- 123-I INER
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jan 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is aged 18-65.
- Written informed consent is obtained.
- The subject has a negative history of neurological or psychiatric illness based on evaluation by a research physician.
- For females, non-child bearing potential or negative urine pregnancy test on day of [123I] INER injection.
Who cannot join
- The subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Use of all prescription drugs or non-prescriptions drugs that may effect norepinephrine such as cold remedies (for 2 weeks prior to injection).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
Official title: Phase 1 Assessment of the Biodistribution and Safety of 123-I INER in Healthy Subjects
The initial study of [123I] INER will be completed in two parts. Once Part A (Preliminary whole body biodistribution) is completed, Part B (Serial dynamic SPECT assessment of regional brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and regional distribution and washout counts following 123-I INER injection) will commence. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, and a baseline physical and neurological evaluation.
Read the detailed description
All subjects will receive a full physical examination at IND to determine study eligibility. Written informed consent will be obtained prior to any study procedures. The screening procedures will include: review of medical and psychiatric history, review of medications, physical examination including height and body weight, vital sign measurements, review of inclusion/exclusion criteria, clinical laboratory testing (serum chemistries, CBC, urinalysis, urinary drug screen), urine pregnancy test for females of childbearing potential and electrocardiogram in preparation for the imaging study.
Part A: Four healthy subjects will each receive one injection of 123-I INER. Serial whole body planar imaging in the anterior and posterior projection will be performed over the 8-9 hour period following injection of 5 mCi of 123-I INER and again at 18-24 hours following injection. Venous blood data will be acquired at each imaging time point. In addition a 24 hour urine collection will commence following radiotracer injection. Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs. Plasma and urine metabolites will be characterized and safety assessments obtained. Serial safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKGs.
Part B: Six healthy subjects will each receive one injection of 123-I INER. Following bolus intravenous injection of 5 mCi of 123-I INER over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I INER and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKGs.
- Conditions
- Neurodegenerative Diseases
- Being tested
- 123-I INER
- Keywords
- SPECT, Nuclear Medicine
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
123-I INERDrug
Serial whole body planar imaging in the anterior and posterior projection will be performed at 1 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, and 18-24h following injection of 5 mCi of 123-I INER. Venous blood data will be acquired at each imaging time point. In addition a 24 hour urine collection will commence following radiotracer injection and urine sampled in five collections every 4 hours collection for first sixteen hours (4 collections), then one collection from 16 to 24 h. Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs using the MIRD method as described previously (Seibyl, et al, 1993). Plasma and urine metabolites will be characterized and safety assessments obtained.
| Study group | Role | What they receive |
|---|---|---|
| 123-I INER | Experimental | To assess 123-I INER Receives: Drug: 123-I INER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the biodistribution and metabolic rate of 123-I INER for determination of radiation absorbed dose estimates.
Measured: 2 yrs
Secondary outcomes (1)
Assess of regional brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and regional distribution and washout counts following 123-I INER injection.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Molecular NeuroImaging
- Responsible party
- Principal investigator, John Seibyl, MD, Institute for Neurodegenerative Disorders
- Investigators
- John Seibyl, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316797
- Sponsor's protocol ID
- H01_INER_001/002
- Status last verified
- Apr 2014
- First submitted
- 19 Apr 2006
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abi-Dargham A, Innis RB, Wisniewski G, Baldwin RM, Neumeyer JL, Seibyl JP. Human biodistribution and dosimetry of iodine-123-fluoroalkyl analogs of beta-CIT. Eur J Nucl Med. 1997 Nov;24(11):1422-5. doi: 10.1007/s002590050170.
PubMed 9371877Dey HM, Seibyl JP, Stubbs JB, Zoghbi SS, Baldwin RM, Smith EO, Zubal IG, Zea-Ponce Y, Olson C, Charney DS, et al. Human biodistribution and dosimetry of the SPECT benzodiazepine receptor radioligand iodine-123-iomazenil. J Nucl Med. 1994 Mar;35(3):399-404.
PubMed 8113883Fujita M, Seibyl JP, Vaupel DB, Tamagnan G, Early M, Zoghbi SS, Baldwin RM, Horti AG, KoreN AO, Mukhin AG, Khan S, Bozkurt A, Kimes AS, London ED, Innis RB. Whole-body biodistribution, radiation absorbed dose, and brain SPET imaging with [123i]5-i-A-85380 in healthy human subjects. Eur J Nucl Med Mol Imaging. 2002 Feb;29(2):183-90. doi: 10.1007/s00259-001-0695-z.
PubMed 11926380Seibyl JP, Wallace E, Smith EO, Stabin M, Baldwin RM, Zoghbi S, Zea-Ponce Y, Gao Y, Zhang WY, Neumeyer JL, et al. Whole-body biodistribution, radiation absorbed dose and brain SPECT imaging with iodine-123-beta-CIT in healthy human subjects. J Nucl Med. 1994 May;35(5):764-70.
PubMed 8176456
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Assessment of the Biodistribution and Safety of 123-I INER in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00316797
- Acronym / sponsor ID
- H01_INER_001/002
- Conditions
- Neurodegenerative Diseases
- Keywords
- SPECT, Nuclear Medicine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Collaborators
- Molecular NeuroImaging
- Study start
- Apr 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Apr 2006 (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 initial study of [123I] INER will be completed in two parts. Once Part A (Preliminary whole body biodistribution) is completed, Part B (Serial dynamic SPECT assessment of regional brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and regional distribution and washout counts following 123-I INER injection) will commence. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, and a baseline physical and neurological evaluation.
Detailed description
All subjects will receive a full physical examination at IND to determine study eligibility. Written informed consent will be obtained prior to any study procedures. The screening procedures will include: review of medical and psychiatric history, review of medications, physical examination including height and body weight, vital sign measurements, review of inclusion/exclusion criteria, clinical laboratory testing (serum chemistries, CBC, urinalysis, urinary drug screen), urine pregnancy test for females of childbearing potential and electrocardiogram in preparation for the imaging study.
Part A: Four healthy subjects will each receive one injection of 123-I INER. Serial whole body planar imaging in the anterior and posterior projection will be performed over the 8-9 hour period following injection of 5 mCi of 123-I INER and again at 18-24 hours following injection. Venous blood data will be acquired at each imaging time point. In addition a 24 hour urine collection will commence following radiotracer injection. Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs. Plasma and urine metabolites will be characterized and safety assessments obtained. Serial safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKGs.
Part B: Six healthy subjects will each receive one injection of 123-I INER. Following bolus intravenous injection of 5 mCi of 123-I INER over 15 seconds, serial dynamic SPECT brain acquisitions will be obtained to evaluate the regional brain uptake and washout of activity. Venous blood measures will be obtained with each acquisition and characterization of 123-I INER and metabolites will be assessed. Safety assessments will include vital signs, serum chemistries, CBC, urinalysis, and EKGs.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 123-I INER | Experimental | Drug: 123-I INERTo assess 123-I INER |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject is aged 18-65.
- Written informed consent is obtained.
- The subject has a negative history of neurological or psychiatric illness based on evaluation by a research physician.
- For females, non-child bearing potential or negative urine pregnancy test on day of [123I] INER injection.
Key exclusion criteria (5 listed)
- The subject has a clinically significant clinical laboratory values abnormality, and/or medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Use of all prescription drugs or non-prescriptions drugs that may effect norepinephrine such as cold remedies (for 2 weeks prior to injection).
- Pregnancy
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 |
|---|---|---|
| 123-I INERSerial whole body planar imaging in the anterior and posterior projection will be performed at 1 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, and 18-24h following injection of 5 mCi of 123-I INER. Venous blood data will be acquired at each imaging time point. In addition a 24 hour urine collection will commence following radiotracer injection and urine sampled in five collections every 4 hours collection for first sixteen hours (4 collections), then one collection from 16 to 24 h. Whole body and source organs uptake will be analyzed on anterior and posterior images for calculating the radiation absorbed doses to organs using the MIRD method as described previously (Seibyl, et al, 1993). Plasma and urine metabolites will be characterized and safety assessments obtained. | Drug | 123-I INER |
Primary outcome
Assess the biodistribution and metabolic rate of 123-I INER for determination of radiation absorbed dose estimates.
Time frame: 2 yrs
1 secondary outcome
Assess of regional brain uptake and washout and plasma metabolite analysis to determine the brain penetrance and regional distribution and washout counts following 123-I INER injection.
Time frame: 2 years
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 Apr 2014.
- Background: PubMed 9371877Abi-Dargham A, Innis RB, Wisniewski G, Baldwin RM, Neumeyer JL, Seibyl JP. Human biodistribution and dosimetry of iodine-123-fluoroalkyl analogs of beta-CIT. Eur J Nucl Med. 1997 Nov;24(11):1422-5. doi: 10.1007/s002590050170.
- Background: PubMed 8113883Dey HM, Seibyl JP, Stubbs JB, Zoghbi SS, Baldwin RM, Smith EO, Zubal IG, Zea-Ponce Y, Olson C, Charney DS, et al. Human biodistribution and dosimetry of the SPECT benzodiazepine receptor radioligand iodine-123-iomazenil. J Nucl Med. 1994 Mar;35(3):399-404.
- Background: PubMed 11926380Fujita M, Seibyl JP, Vaupel DB, Tamagnan G, Early M, Zoghbi SS, Baldwin RM, Horti AG, KoreN AO, Mukhin AG, Khan S, Bozkurt A, Kimes AS, London ED, Innis RB. Whole-body biodistribution, radiation absorbed dose, and brain SPET imaging with [123i]5-i-A-85380 in healthy human subjects. Eur J Nucl Med Mol Imaging. 2002 Feb;29(2):183-90. doi: 10.1007/s00259-001-0695-z.
- Background: PubMed 8176456Seibyl JP, Wallace E, Smith EO, Stabin M, Baldwin RM, Zoghbi S, Zea-Ponce Y, Gao Y, Zhang WY, Neumeyer JL, et al. Whole-body biodistribution, radiation absorbed dose and brain SPECT imaging with iodine-123-beta-CIT in healthy human subjects. J Nucl Med. 1994 May;35(5):764-70.
- Institute for Neurodegenerative DisordersLink provided by the sponsor.
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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.
John Seibyl, MD principal investigator
Institute for Neurodegenerative Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 123-I INER in people with Neurodegenerative Diseases, run by Institute for Neurodegenerative Disorders at 1 site 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 5 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Assess the biodistribution and metabolic rate of 123-I INER for determination of radiation absorbed dose estimates. (time frame: 2 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316797, which also lists 4 linked publications.
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 Apr 2014.