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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TS-121; Drug: [11C]TASP0410699; Radiation: Positron Emission Tomography (PET)

• Registration Number: NCT02448212
• Lead Sponsor: Taisho Pharmaceutical R&D Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-19
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PART 1 (Test/Retest)	Positron Emission Tomography (PET)	Dosing with \[11C\]TASP0410699 for PET imaging without dosing of TS-121
PART 2 (PET Receptor Occupancy Study)	TS-121	Dosing with \[11C\]TASP0410699 for PET imaging with dosing of TS-121
PART 1 (Test/Retest)	[11C]TASP0410699	Dosing with \[11C\]TASP0410699 for PET imaging without dosing of TS-121
PART 2 (PET Receptor Occupancy Study)	[11C]TASP0410699	Dosing with \[11C\]TASP0410699 for PET imaging with dosing of TS-121
PART 2 (PET Receptor Occupancy Study)	Positron Emission Tomography (PET)	Dosing with \[11C\]TASP0410699 for PET imaging with dosing of TS-121

Primary Outcome Measures

Name	Time	Method
Positron emission tomography measure (receptor occupancy)	Day 1 through Day 3

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of TS-121	Day 1 through Day 3	Time to attain cmax (Tmax)
Composite safety as assessed by clinical laboratory tests, 12-lead ECG, vital signs, adverse events and physical examinations	up to Day 11

Trial Locations

Locations (1)

Yale University PET Center; 🇺🇸 New Haven, Connecticut, United States