NCT02448212

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2015

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

May 13, 2015

Last Update Submit

February 10, 2017

Conditions

Healthy

Keywords

PETReceptor Occupancy

Outcome Measures

Primary Outcomes (1)

  • Positron emission tomography measure (receptor occupancy)

    Day 1 through Day 3

Secondary Outcomes (4)

  • Pharmacokinetic parameters of TS-121

    Day 1 through Day 3

  • Pharmacokinetic parameters of TS-121

    Day 1 through Day 3

  • Pharmacokinetic parameters of TS-121

    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

Study Arms (2)

PART 1 (Test/Retest)

EXPERIMENTAL

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

Drug: [11C]TASP0410699Radiation: Positron Emission Tomography (PET)

PART 2 (PET Receptor Occupancy Study)

EXPERIMENTAL

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

Drug: TS-121Drug: [11C]TASP0410699Radiation: Positron Emission Tomography (PET)

Interventions

TS-121DRUG

Oral

PART 2 (PET Receptor Occupancy Study)
[11C]TASP0410699DRUG

Intravenous radiotracer

PART 1 (Test/Retest)PART 2 (PET Receptor Occupancy Study)
Positron Emission Tomography (PET)RADIATION

Imaging scanning procedure

PART 1 (Test/Retest)PART 2 (PET Receptor Occupancy Study)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males 18 - 55 years of age (at time of initial informed consent)
  • Body weight ≥ 50 kg
  • Body Mass Index (BMI) 18 - 30 kg/m2
  • Male subjects with partners of childbearing potential must agree to use appropriate and effective measures of contraception for 90 days following drug administration

You may not qualify if:

  • Prescription, over-the-counter or herbal medications, supplements, within 14 days before the study.
  • Clinically significant abnormal electrocardiogram, physical examination, or hematology, biochemistry, hormone, or urinalysis values at screening \& baseline.
  • 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.
  • 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.
  • History \&/or current evidence of serologic positive results for hepatitis B or C, or HIV.
  • Donation or acute loss of 450 milliliters or more of blood or plasma, within 60 days of the study.
  • Any subject who has received treatment with a non-FDA approved drug within 30 days of study screening.
  • Subjects who suffer from claustrophobia.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University PET Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

TASP0410699Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Richard E. Carson, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

  • Shoji Yasuda

    Taisho Pharmaceutical R&D Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 19, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

US(1)