NCT01879722

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Subjects With Stable Schizophrenia and Healthy Japanese Subjects

Completed Phase 1 Results posted Last updated 17 April 2026

What this trial tests

Phase 1 trial testing TAK-063 in Schizophrenia in 77 participants. Completed in 1 June 2014.

Timeline

1 June 2013

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	77
Start date	1 June 2013
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	1 location across United States

Drugs / interventions tested

• TAK-063 — full drug profile →
• TAK-063 Placebo

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 55, any sex, with Schizophrenia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing
  Time frame: Day 1 to Day 14
  An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whethe
• Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
  Time frame: Day 1 to Day 8
  The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
• Percentage of Participants With Markedly Abnormal Vital Sign Measurements
  Time frame: Day 1 to Day 8
  The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing
• Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
  Time frame: Day 1 to Day 8
  The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.

Sponsor's own description

The purpose of this study is to characterize the safety and tolerability of TAK-063 when administered as multiple oral doses at escalating dose levels in participants with stable schizophrenia and in healthy Japanese participants.

Publications & conference data

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

1. Advances in targeting cyclic nucleotide phosphodiesterases.
   Maurice DH, Ke H, Ahmad F, Wang Y, et al · · 2014 · cited 597× · PMID 24687066 · DOI 10.1038/nrd4228
2. A phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-063, a selective PDE10A inhibitor.
   Tsai M, Chrones L, Xie J, Gevorkyan H, et al · · 2016 · cited 19× · PMID 27572830 · DOI 10.1007/s00213-016-4412-9
3. A Randomized Multiple Dose Pharmacokinetic Study of a Novel PDE10A Inhibitor TAK-063 in Subjects with Stable Schizophrenia and Japanese Subjects and Modeling of Exposure Relationships to Adverse Events.
   Goldsmith P, Affinito J, McCue M, Tsai M, et al · · 2017 · cited 14× · PMID 29103081 · DOI 10.1007/s40268-017-0214-8
4. Translational Development Strategies for TAK-063, a Phosphodiesterase 10A Inhibitor.
   Macek TA, Suzuki K, Asin K, Kimura H. · · 2020 · cited 6× · PMID 32598478 · DOI 10.1093/ijnp/pyaa042
5. Progress in mechanistically novel treatments for schizophrenia.
   Neef J, Palacios DS. · · 2021 · cited 5× · PMID 34671731 · DOI 10.1039/d1md00096a