Exploratory Study Using Positron Emission Tomography With TS-121 and [11C]TASP0410699 in Healthy Adult Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PART 1 (Test/Retest)

Dosing with \[11C\]TASP0410699 for PET imaging without dosing of TS-121

Group Type EXPERIMENTAL

[11C]TASP0410699

Intervention Type DRUG

Intravenous radiotracer

Positron Emission Tomography (PET)

Intervention Type RADIATION

Imaging scanning procedure

PART 2 (PET Receptor Occupancy Study)

Dosing with \[11C\]TASP0410699 for PET imaging with dosing of TS-121

Group Type EXPERIMENTAL

TS-121

Intervention Type DRUG

Oral

[11C]TASP0410699

Intervention Type DRUG

Intravenous radiotracer

Positron Emission Tomography (PET)

Intervention Type RADIATION

Imaging scanning procedure

Interventions

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TS-121

Oral

Intervention Type DRUG

[11C]TASP0410699

Intravenous radiotracer

Intervention Type DRUG

Positron Emission Tomography (PET)

Imaging scanning procedure

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Healthy males 18 - 55 years of age (at time of initial informed consent)
2. Body weight ≥ 50 kg
3. Body Mass Index (BMI) 18 - 30 kg/m2
4. Male subjects with partners of childbearing potential must agree to use appropriate and effective measures of contraception for 90 days following drug administration

Exclusion Criteria

1. Prescription, over-the-counter or herbal medications, supplements, within 14 days before the study.
2. Clinically significant abnormal electrocardiogram, physical examination, or hematology, biochemistry, hormone, or urinalysis values at screening \& baseline.
3. 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.
4. 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.
5. History \&/or current evidence of serologic positive results for hepatitis B or C, or HIV.
6. Donation or acute loss of 450 milliliters or more of blood or plasma, within 60 days of the study.
7. Any subject who has received treatment with a non-FDA approved drug within 30 days of study screening.
8. Subjects who suffer from claustrophobia.
9. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes