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Clinical trial

A Phase I Study of TS-142 in Non-Elderly Healthy Participants (Repeated Doses) (A Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Non-Elderly Participants)

ID
Name
TS142-102
Description
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.
Trial arms
Trial start
2016-07-06
Estimated PCD
2016-10-08
Trial end
2016-10-08
Status
Completed
Phase
Early phase I
Treatment
Placebo
Participants will receive placebo once daily for 7 consective days
Arms:
Placebo, TS-142 10 mg, TS-142 20 mg, TS-142 30 mg
TS-142, 10 mg
Participants will receive 10 mg of TS-142 once daily for 7 consective days
Arms:
Placebo, TS-142 10 mg, TS-142 20 mg, TS-142 30 mg
TS-142, 20 mg
Participants will receive 20 mg of TS-142 once daily for 7 consective days
Arms:
Placebo, TS-142 10 mg, TS-142 20 mg, TS-142 30 mg
TS-142, 30 mg
Participants will receive 30 mg of TS-142 once daily for 7 consective days
Arms:
Placebo, TS-142 10 mg, TS-142 20 mg, TS-142 30 mg
Size
24
Primary endpoint
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Day 1 up to Day 14
Area under the concentration-time curve AUC (tau)
Day 1 up to Day 9
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2023-10-26

1 organization

2 products

1 indication

Organization
Taisho Pharmaceutical
Product
TS-142
Indication
Healthy Volunteer
Product
Placebo