HealthyPhase 1NCT02448212
Exploratory Study Using Positron Emission Tomography With TS-121 and [11C]TASP0410699 in Healthy Adult Male Subjects
A Phase 1 study testing TS-121, [11C]TASP0410699 and Positron Emission Tomography (PET) in people with Healthy, run by Taisho Pharmaceutical R&D Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699, using Positron Emission Tomography (PET) scans with or without dosing of TS-121 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TS-121, [11C]TASP0410699 and Positron Emission Tomography (PET)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Apr 2016
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males 18 - 55 years of age (at time of initial informed consent)
- Body weight ≥ 50 kg
- Body Mass Index (BMI) 18 - 30 kg/m2
- Male subjects with partners of childbearing potential must agree to use appropriate and effective measures of contraception for 90 days following drug administration
Who cannot join
- Prescription, over-the-counter or herbal medications, supplements, within 14 days before the study.
- Clinically significant abnormal electrocardiogram, physical examination, or hematology, biochemistry, hormone, or urinalysis values at screening \& baseline.
- Significant history \&/or presence of hepatic, renal, cardiovascular, hemodynamic, pulmonary, gastrointestinal, hematological, CNS, immunologic, ophthalmologic, metabolic, endocrine, or oncological disease or condition within last 5 years.
- Current use of tobacco or tobacco-containing products, recent history of alcohol or drug abuse OR positive urine screen for alcohol or controlled substances at screening or baseline.
- History \&/or current evidence of serologic positive results for hepatitis B or C, or HIV.
- Donation or acute loss of 450 milliliters or more of blood or plasma, within 60 days of the study.
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- Any subject who has received treatment with a non-FDA approved drug within 30 days of study screening.
- Subjects who suffer from claustrophobia.
- Current, past, or anticipated exposure to radiation in the workplace or participation in other research studies involving ionizing radiation that would exceed the yearly dose limits for normal subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University PET Center
New Haven, Connecticut, 06520
About this study
Official title: A Phase 1 Receptor Occupancy Study Using Positron Emission Tomography to Investigate Novel Ligand [11C]TASP0410699 Alone and Following Single Oral Dose Administrations of TS-121 in Healthy Adult (Male) Subjects
The purpose of this study is to evaluate the binding of a novel tracer, [11C]TASP0410699, using Positron Emission Tomography (PET) scans with or without dosing of TS-121
- Conditions
- Healthy
- Being tested
- TS-121, [11C]TASP0410699, Positron Emission Tomography (PET)
- Keywords
- PET, Receptor Occupancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-121Drug
Oral
[11C]TASP0410699Drug
Intravenous radiotracer
Positron Emission Tomography (PET)Radiation
Imaging scanning procedure
| Study group | Role | What they receive |
|---|---|---|
| PART 1 (Test/Retest) | Experimental | Dosing with [11C]TASP0410699 for PET imaging without dosing of TS-121 Receives: Drug: [11C]TASP0410699; Radiation: Positron Emission Tomography (PET) |
| PART 2 (PET Receptor Occupancy Study) | Experimental | Dosing with [11C]TASP0410699 for PET imaging with dosing of TS-121 Receives: Drug: TS-121; Drug: [11C]TASP0410699; Radiation: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron emission tomography measure (receptor occupancy)
Measured: Day 1 through Day 3
Secondary outcomes (4)
Pharmacokinetic parameters of TS-121
Area under the plasma concentration (AUC) from time zero to time of last measurable concentration
Measured: Day 1 through Day 3
Pharmacokinetic parameters of TS-121
Maximum concentration (Cmax)
Measured: Day 1 through Day 3
Pharmacokinetic parameters of TS-121
Time to attain cmax (Tmax)
Measured: Day 1 through Day 3
Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations
Measured: up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Richard E. Carson, Ph.D., Principal investigator, Yale UniversityShoji Yasuda, Study director, Taisho Pharmaceutical R&D Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448212
- Sponsor's protocol ID
- TS121-US103
- Status last verified
- Feb 2017
- First submitted
- 13 May 2015
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Receptor Occupancy Study Using Positron Emission Tomography to Investigate Novel Ligand [11C]TASP0410699 Alone and Following Single Oral Dose Administrations of TS-121 in Healthy Adult (Male) Subjects
- ClinicalTrials.gov ID
- NCT02448212
- Acronym / sponsor ID
- TS121-US103
- Conditions
- Healthy
- Keywords
- PET, Receptor Occupancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 May 2015 (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 study is to evaluate the binding of a novel tracer, [11C]TASP0410699, using Positron Emission Tomography (PET) scans with or without dosing of TS-121
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PART 1 (Test/Retest) | Experimental | Drug: [11C]TASP0410699, Radiation: Positron Emission Tomography (PET)Dosing with [11C]TASP0410699 for PET imaging without dosing of TS-121 |
| PART 2 (PET Receptor Occupancy Study) | Experimental | Drug: TS-121, Drug: [11C]TASP0410699, Radiation: Positron Emission Tomography (PET)Dosing with [11C]TASP0410699 for PET imaging with dosing of TS-121 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males 18 - 55 years of age (at time of initial informed consent)
- Body weight ≥ 50 kg
- Body Mass Index (BMI) 18 - 30 kg/m2
- Male subjects with partners of childbearing potential must agree to use appropriate and effective measures of contraception for 90 days following drug administration
Key exclusion criteria (9 listed)
- Prescription, over-the-counter or herbal medications, supplements, within 14 days before the study.
- Clinically significant abnormal electrocardiogram, physical examination, or hematology, biochemistry, hormone, or urinalysis values at screening \& baseline.
- Significant history \&/or presence of hepatic, renal, cardiovascular, hemodynamic, pulmonary, gastrointestinal, hematological, CNS, immunologic, ophthalmologic, metabolic, endocrine, or oncological disease or condition within last 5 years.
- Current use of tobacco or tobacco-containing products, recent history of alcohol or drug abuse OR positive urine screen for alcohol or controlled substances at screening or baseline.
- History \&/or current evidence of serologic positive results for hepatitis B or C, or HIV.
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 |
|---|---|---|
| TS-121Oral | Drug | PART 2 (PET Receptor Occupancy Study) |
| [11C]TASP0410699Intravenous radiotracer | Drug | PART 1 (Test/Retest), PART 2 (PET Receptor Occupancy Study) |
| Positron Emission Tomography (PET)Imaging scanning procedure | Radiation | PART 1 (Test/Retest), PART 2 (PET Receptor Occupancy Study) |
Primary outcome
Positron emission tomography measure (receptor occupancy)
Time frame: Day 1 through Day 3
4 secondary outcomes
Pharmacokinetic parameters of TS-121
Time frame: Day 1 through Day 3
Pharmacokinetic parameters of TS-121
Time frame: Day 1 through Day 3
Pharmacokinetic parameters of TS-121
Time frame: Day 1 through Day 3
Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations
Time frame: up to Day 11
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 14 Feb 2017.
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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.
Richard E. Carson, Ph.D. principal investigator
Yale University
Shoji Yasuda study director
Taisho Pharmaceutical R&D Inc.
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 TS-121, [11C]TASP0410699 and Positron Emission Tomography (PET) in people with Healthy, run by Taisho Pharmaceutical R&D Inc. 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 9 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 14 Feb 2017. 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?
Positron emission tomography measure (receptor occupancy) (time frame: Day 1 through Day 3). 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 14 Feb 2017.