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

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Radiation: Positron Emission Tomography (PET); Drug: TS-121; Drug: [11C]TASP0410699

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02448212

TS121-US103

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

PART 1 (Test/Retest)

Experimental group

Description:

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

Treatment:

Drug: [11C]TASP0410699

Radiation: Positron Emission Tomography (PET)

PART 2 (PET Receptor Occupancy Study)

Experimental group

Description:

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

Treatment:

Drug: [11C]TASP0410699

Drug: TS-121

Radiation: Positron Emission Tomography (PET)