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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:May 2015

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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


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.
We found this trial at
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New Haven, Connecticut 06519
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New Haven, CT
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