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NCT03914755
A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects
Phase 1 trial testing Tucatinib in Healthy in 36 participants. Completed in 4 August 2019.
4 August 2019
Quick facts
| Lead sponsor | Seagen Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 8 May 2019 |
| Primary completion | 4 August 2019 |
| Estimated completion | 4 August 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tucatinib (tucatinib) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Seagen Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is being done to compare the pharmacokinetics (PK) and safety/tolerability of tucatinib in healthy Japanese and Caucasian participants. Three cohorts of healthy Japanese and Caucasian men and women will be admitted to the Clinical Research Unit (CRU) and receive multiple oral doses of tucatinib over 14 days with and without food. Subjects will be in the study for up to 45 days, including the screening period. Due to practical considerations, each cohort will be dosed sequentially (this is not a dose escalation study).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer.
Zhang D, Taylor A, Zhao JJ, Endres CJ, et al · · 2024 · cited 2× · PMID 39368039 · DOI 10.1007/s40262-024-01412-0
Verify or expand the search:
- PubMed search for NCT03914755
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tucatinib
Trials testing the same drug.
- NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07318389 — ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer · EARLY_PHASE1 · not yet recruiting
- NCT07413939 — RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastati · Phase 2, PHASE3 · not yet recruiting
- NCT06961331 — Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for th · completed
- NCT06686394 — Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Sp · Phase 1, PHASE2 · recruiting
Other recruiting trials for Healthy
Currently open trials in the same condition.
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- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Seagen Inc. trials
Trials by the same sponsor.
- NCT05244473 — A Safety Study of Brentuximab Vedotin in Participants With HIV · Phase 1 · withdrawn
- NCT05229900 — A Study of SGN-ALPV in Advanced Solid Tumors · Phase 1 · terminated
- NCT04993677 — A Study of SEA-CD40 Given With Other Drugs in Cancers · Phase 2 · completed
- NCT04499924 — Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastro · Phase 2, PHASE3 · completed
- NCT04665921 — A Study of SGN-STNV in Advanced Solid Tumors · Phase 1 · terminated
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 NCT03914755 (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 Seagen Inc.
- Last refreshed: 6 September 2019
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/NCT03914755.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing