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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02448212

Enrollment

Registered

2015-05-19

Start date

2015-05-31

Completion date

2016-04-30

Last updated

2017-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PET, Receptor Occupancy

Brief 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

Interventions

DRUGTS-121

Oral

DRUG[11C]TASP0410699

Intravenous radiotracer

RADIATIONPositron Emission Tomography (PET)

Imaging scanning procedure

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Positron emission tomography measure (receptor occupancy)	Day 1 through Day 3

Secondary

Measure	Time frame	Description
Pharmacokinetic parameters of TS-121	Day 1 through Day 3	Area under the plasma concentration (AUC) from time zero to time of last measurable concentration
Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations	up to Day 11	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026