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OpenTrials
Completed

NCT Number: NCT02448212

Exploratory Study Using Positron Emission Tomography With TS-121 and [11C]TASP0410699 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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yale University PET Center

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

TS-121

Drug

Oral

[11C]TASP0410699

Drug

Intravenous radiotracer

Positron Emission Tomography (PET)

Radiation

Imaging scanning procedure

Primary outcomes

  1. Positron emission tomography measure (receptor occupancy)

    Time frame: Day 1 through Day 3

Secondary outcomes

  1. Pharmacokinetic parameters of TS-121

    Time frame: 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

    Time frame: Day 1 through Day 3

    Maximum concentration (Cmax)

  3. Pharmacokinetic parameters of TS-121

    Time frame: 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

    Time frame: up to Day 11

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical R&D Inc.

Industry

Collaborators

  • Yale University

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 19, 2015
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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