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

Sponsor
Taisho Pharmaceutical R&D Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02448212
Collaborator
Yale University (Other)
15
Enrollment
1
Location
2
Arms
11
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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 Start Date :
May 1, 2015
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: PART 1 (Test/Retest)

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

Drug: [11C]TASP0410699
Intravenous radiotracer

Radiation: Positron Emission Tomography (PET)
Imaging scanning procedure
Experimental: PART 2 (PET Receptor Occupancy Study)

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

Drug: TS-121
Oral

Drug: [11C]TASP0410699
Intravenous radiotracer

Radiation: Positron Emission Tomography (PET)
Imaging scanning procedure

Outcome Measures

Primary Outcome Measures

  1. Positron emission tomography measure (receptor occupancy) [Day 1 through Day 3]

Secondary Outcome Measures

  1. 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

  2. Pharmacokinetic parameters of TS-121 [Day 1 through Day 3]

    Maximum concentration (Cmax)

  3. Pharmacokinetic parameters of TS-121 [Day 1 through Day 3]

    Time to attain cmax (Tmax)

  4. Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations [up to Day 11]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University PET Center New Haven Connecticut United States 06520

Sponsors and Collaborators

  • Taisho Pharmaceutical R&D Inc.
  • Yale University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier:
NCT02448212
Other Study ID Numbers:
  • TS121-US103
First Posted:
May 19, 2015
Last Update Posted:
Feb 14, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Taisho Pharmaceutical R&D Inc.
PET
Receptor Occupancy

Study Results

No Results Posted as of Feb 14, 2017