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A Phase I Study of TS-142 in Healthy Participants (Repeated Doses)

Taisho Pharmaceutical logo

Taisho Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Placebo
Drug: TS-142, 10 mg
Drug: TS-142, 30 mg
Drug: TS-142, 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04169906
TS142-102

Details and patient eligibility

About

The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly participants.

Enrollment

24 patients

Sex

Male

Ages

20 to 39 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 at screening inspection

Exclusion criteria

  • History of clinically relevant disease of some organ systems that may be considerd inappropriately for this study
  • History of drug and food allergy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

24 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: TS-142, 20 mg
Drug: TS-142, 30 mg
Drug: TS-142, 10 mg
Drug: Placebo
TS-142 10 mg
Experimental group
Treatment:
Drug: TS-142, 20 mg
Drug: TS-142, 30 mg
Drug: TS-142, 10 mg
Drug: Placebo
TS-142 20 mg
Experimental group
Treatment:
Drug: TS-142, 20 mg
Drug: TS-142, 30 mg
Drug: TS-142, 10 mg
Drug: Placebo
TS-142 30 mg
Experimental group
Treatment:
Drug: TS-142, 20 mg
Drug: TS-142, 30 mg
Drug: TS-142, 10 mg
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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