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NCT03525405
A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
Phase 1 trial testing napabucasin in ADME in 8 participants. Completed in 2 June 2018.
2 June 2018
Quick facts
| Lead sponsor | Sumitomo Pharma America, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 18 May 2018 |
| Primary completion | 2 June 2018 |
| Estimated completion | 2 June 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- napabucasin — full drug profile →
Conditions studied
Sponsor
Sumitomo Pharma America, Inc. — full company profile →
Who can join
Adults 18 to 45, male only, with ADME or Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Unraveling the complexity of STAT3 in cancer: molecular understanding and drug discovery.
Hu Y, Dong Z, Liu K. · · 2024 · cited 159× · PMID 38245798 · DOI 10.1186/s13046-024-02949-5 -
Mass balance and pharmacokinetics of an oral dose of <sup>14</sup> C-napabucasin in healthy adult male subjects.
Dai X, Karol MD, Hitron M, Hard ML, et al · · 2021 · cited 7× · PMID 33576192 · DOI 10.1002/prp2.722 -
Napabucasin Drug-Drug Interaction Potential, Safety, Tolerability, and Pharmacokinetics Following Oral Dosing in Healthy Adult Volunteers.
Dai X, Karol MD, Hitron M, Hard ML, et al · · 2021 · cited 6× · PMID 34107166 · DOI 10.1002/cpdd.961
Verify or expand the search:
- PubMed search for NCT03525405
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of napabucasin
Trials testing the same drug.
- NCT03411122 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy · Phase 1 · completed
Other Sumitomo Pharma America, Inc. trials
Trials by the same sponsor.
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- NCT06517940 — A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP) · active not recruiting
- NCT07492355 — TP-3654 Food Effect Study · Phase 1 · completed
- NCT06037668 — A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety D · NA · completed
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 NCT03525405 (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 Sumitomo Pharma America, Inc.
- Last refreshed: 8 November 2023
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/NCT03525405.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing