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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Radiation: Positron Emission Tomography (PET); Drug: [11C]TASP0410699; Drug: TS-121

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University PET Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PART 1 (Test/Retest); Dosing with [11C]TASP0410699 for PET imaging without dosing of TS-121	Radiation: Positron Emission Tomography (PET); Imaging scanning procedure; Drug: [11C]TASP0410699; Intravenous radiotracer
Experimental: PART 2 (PET Receptor Occupancy Study); Dosing with [11C]TASP0410699 for PET imaging with dosing of TS-121	Radiation: Positron Emission Tomography (PET); Imaging scanning procedure; Drug: [11C]TASP0410699; Intravenous radiotracer; Drug: TS-121; Oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical R&D Inc.
• Collaborators: Yale University
• Investigators: Principal Investigator: Richard E. Carson, Ph.D., Yale University; Study Director: Shoji Yasuda, Taisho Pharmaceutical R&D Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: PET; Receptor Occupancy
• Other Study ID Numbers: TS121-US103