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NCT03777761
Effects of Tucatinib on Cardiac Repolarization in Healthy Participants
Phase 1 trial testing tucatinib in Healthy in 55 participants. Completed in 11 March 2019.
11 March 2019
Quick facts
| Lead sponsor | Seagen Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 6 December 2018 |
| Primary completion | 11 March 2019 |
| Estimated completion | 11 March 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- tucatinib (tucatinib) — full drug profile →
- placebo
- moxifloxacin (moxifloxacin) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Seagen Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. One part will be to take the study drug, the second part will be to take a placebo (pill with no medicine), and the third part will be to take moxifloxacin. The volunteers will only know what part of the study they are in when they take moxifloxacin. For the study drug and placebo parts, volunteers will take 2 pills by mouth for 5 days. For the moxifloxacin part, volunteers will take 1 pill by mouth for 1 day.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cardiovascular Toxicity of Novel HER2-Targeted Therapies in the Treatment of Breast Cancer.
Dent SF, Morse A, Burnette S, Guha A, et al · · 2021 · cited 40× · PMID 34453232 · DOI 10.1007/s11912-021-01114-x -
Effect of Tucatinib on Cardiac Repolarization in Healthy Volunteers.
Topletz-Erickson AR, Mayor JG, Liu HT, Abdulrasool LI, et al · · 2023 · PMID 37751113 · DOI 10.1007/s40268-023-00440-8
Verify or expand the search:
- PubMed search for NCT03777761
- 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.
- NCT06157892 — A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors · Phase 2 · recruiting
- NCT05253651 — A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colo · Phase 3 · recruiting
- NCT05091528 — A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers · Phase 1, PHASE2 · terminated
- NCT04499924 — Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastro · Phase 2, PHASE3 · completed
- NCT04579380 — Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations · Phase 2 · active not 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 NCT03777761 (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: 12 April 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/NCT03777761.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing