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NCT03746067

Safety, Tolerability and Pharmacokinetics of Single Doses of TS-134 in Healthy Volunteers

Completed Phase 1 Last updated 19 November 2018
What this trial tests

Phase 1 trial testing TS-134 in Healthy Volunteers in 33 participants. Completed in 13 January 2016.

Timeline
21 August 2015
Primary endpoint
13 January 2016
13 January 2016

Quick facts

Lead sponsorTaisho Pharmaceutical R&D Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment33
Start date21 August 2015
Primary completion13 January 2016
Estimated completion13 January 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Taisho Pharmaceutical R&D Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be evaluated.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety and pharmacokinetic profiles of MGS0274 besylate (TS-134), a novel metabotropic glutamate 2/3 receptor agonist prodrug, in healthy subjects.
    Watanabe M, Marcy B, Kinoshita K, Fukasawa M, et al · · 2020 · cited 12× · PMID 32353162 · DOI 10.1111/bcp.14331
  2. Overview of Novel Antipsychotic Drugs: State of the Art, New Mechanisms, and Clinical Aspects of Promising Compounds.
    Biso L, Carli M, Scarselli M, Longoni B. · · 2025 · cited 8× · PMID 39857669 · DOI 10.3390/biomedicines13010085

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Other trials of TS-134

Trials testing the same drug.

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

Other Taisho Pharmaceutical R&D Inc. trials

Trials by the same sponsor.

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Data sources for this page

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