First-in-Human Study With Single and Multiple Doses of TS-161 in Healthy Participants

NCT ID: NCT03919409

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2020-02-11

Brief Summary

This is a Phase 1, first-in-human study involving single and multiple oral doses of TS-161 in healthy male and female participants. The safety, tolerability, pharmacokinetics and pharmacodynamics of TS-161 will be evaluated.

The study includes 3 parts; Part A (single ascending dose: Cohorts 1 to 5) , Part B (single dose, cerebrospinal fluid [CSF] collection: Cohort 6), and Part C (multiple ascending dose: Cohorts 7 to 9). Participants will be assigned to one of the 9 Cohorts.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part A: Cohort 1: TS-161 15 mg

Single dose of TS-161 15 mg or placebo in a fasted condition.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Part A: Cohort 2: TS-161 50 mg

Single dose of TS-161 50 mg or placebo which will be dosed first in a fasted condition, and then in a fed condition, with a washout period in between 2 dosing. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Part A: Cohort 3: TS-161 100 mg

Single dose of TS-161 100 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Part A: Cohort 4: TS-161 200 mg

Single dose of TS-161 200 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Part A: Cohort 5: TS-161 400 mg

Single dose of TS-161 400 mg or placebo in a fasted condition. Although planned, all subsequent dose levels after Cohort 1 will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Part B: Cohort 6: TS-161 TBD

Single dose of TS-161 in a fasted condition. The dose level will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

Part C: Cohort 7: TS-161 TBD

Daily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Part C: Cohort 8: TS-161 TBD

Daily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Part C: Cohort 9: TS-161 TBD

Daily doses of TS-161 or placebo for 10 days in a fed condition. The dose level will be determined based on the results from the preceding cohorts.

Group Type: EXPERIMENTAL

TS-161

Intervention Type: DRUG

TS-161 capsules

TS-161 Placebo

Intervention Type: DRUG

TS-161 matching placebo capsules

Interventions

TS-161

TS-161 capsules

Intervention Type: DRUG

TS-161 Placebo

TS-161 matching placebo capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adult male and female participants between 18 and 55 years of age, inclusive
• Body weight ≥ 45 kg
• Body Mass Index (BMI) 18 - 30 kg/m^2, inclusive

Exclusion Criteria

• Significant history or presence of medical disorders or condition capable of significantly affecting the absorption, metabolism, or elimination of drugs
• History or presence of psychiatric or neurologic disease or condition
• History of seizures
• Abnormal EEG observed at screening
• Abnormal blood pressure
• Breast cancer within the past 10 years, or any other malignancies within the past 5 years
• Clinically significant abnormal results in electrocardiogram, blood and urine test
• History or presence of liver disease
• Participants using medication or supplements within 14 days prior to dosing
• Use of N-methyl-D-aspartate (NMDA) receptor modulators (example: dextromethorphan, ketamine, amantadine, memantine) within 90 days of screening
• Loss of blood or blood products in excess of 450 mL within 60 days prior to screening
• Used any investigational drug within 60 days prior to screening
• Recent history of alcohol or drug abuse
• Any participant who currently uses or has used tobacco products or nicotine-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) for one month or more prior to screening

• Significant abnormalities in lumbar spine
• History of clinically significant back pain, back pathology, and/or back injury
• History of migraines, and/or frequent, severe headaches
• History or presence of significant active bleeding or coagulation disorder or use of non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion
• Allergy to lidocaine (Xylocaine®) or related drugs
• History of adverse reaction to lumbar puncture or epidural procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taisho Pharmaceutical R&D Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taisho Director

Role: STUDY_DIRECTOR

Taisho Pharmaceutical R&D Inc.

Locations

PAREXEL - Early Phase Clinical Unit-Los Angeles

Glendale, California, United States

Countries

United States

Other Identifiers

TS161-US101

Identifier Type: -

Identifier Source: org_study_id