Clinical trial NCT02448212: Exploratory Study Using Positron Emission Tomography With TS-121 and [11C]TASP0410699 in Healthy Adult Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PET
Receptor Occupancy
Lead sponsor: Taisho Pharmaceutical R&D Inc.
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2015-05-19
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Positron emission tomography measure (receptor occupancy)
timeFrame: Day 1 through Day 3
Secondary outcomes:
measure: Pharmacokinetic parameters of TS-121
timeFrame: Day 1 through Day 3
measure: Pharmacokinetic parameters of TS-121
timeFrame: Day 1 through Day 3
measure: Pharmacokinetic parameters of TS-121
timeFrame: Day 1 through Day 3
measure: Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations
timeFrame: up to Day 11
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University PET Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard E. Carson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taisho Pharmaceutical R&D Inc.
name: Shoji Yasuda
role: STUDY_DIRECTOR
References: