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

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Taisho Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: TS-161
Drug: TS-161 Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03919409
TS161-US101

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion Criteria for Part B only:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 9 patient groups

Part A: Cohort 1: TS-161 15 mg
Experimental group
Description:
Single dose of TS-161 15 mg or placebo in a fasted condition.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161
Part A: Cohort 2: TS-161 50 mg
Experimental group
Description:
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.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161
Part A: Cohort 3: TS-161 100 mg
Experimental group
Description:
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.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161
Part A: Cohort 4: TS-161 200 mg
Experimental group
Description:
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.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161
Part A: Cohort 5: TS-161 400 mg
Experimental group
Description:
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.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161
Part B: Cohort 6: TS-161 TBD
Experimental group
Description:
Single dose of TS-161 in a fasted condition. The dose level will be determined based on the results from the preceding cohorts.
Treatment:
Drug: TS-161
Part C: Cohort 7: TS-161 TBD
Experimental group
Description:
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.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161
Part C: Cohort 8: TS-161 TBD
Experimental group
Description:
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.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161
Part C: Cohort 9: TS-161 TBD
Experimental group
Description:
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.
Treatment:
Drug: TS-161 Placebo
Drug: TS-161

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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