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NCT02370602
An Open-Label [^11C]T-773 Positron Emission Tomography Study to Determine Phosphodiesterase10A Occupancy by TAK-063 After a Single Oral Dose in Human Volunteers
Phase 1 trial testing TAK-063 in Healthy Volunteers in 13 participants. Completed in 1 March 2014.
1 February 2014
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 1 October 2013 |
| Primary completion | 1 February 2014 |
| Estimated completion | 1 March 2014 |
Drugs / interventions tested
- TAK-063 — full drug profile →
- [^11C]T-773 — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Takeda — full company profile →
Who can join
Adults 20 to 45, male only, with Healthy Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 3 Hours Following a Single Dose of TAK-063
Time frame: 3 hours post-dose
Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Occupancy is reported for put
Sponsor's own description
The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain following a single dose of TAK-063.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Novel Role of Cyclic Nucleotide Phosphodiesterase 10A in Pathological Cardiac Remodeling and Dysfunction.
Chen S, Zhang Y, Lighthouse JK, Mickelsen DM, et al · · 2020 · cited 78× · PMID 31801360 · DOI 10.1161/circulationaha.119.042178 -
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
Verify or expand the search:
- PubMed search for NCT02370602
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02370602 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02370602.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing