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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02448212

Run by

Taisho Pharmaceutical R&D Inc.

People needed

15

Starts

2015-05-01

Expected to finish

2016-04-01

Last updated by the study team

2017-02-14

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• 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.

Where it is running

• Yale University PET Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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