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NCT03914755

A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects

Completed Phase 1 Last updated 6 September 2019
What this trial tests

Phase 1 trial testing Tucatinib in Healthy in 36 participants. Completed in 4 August 2019.

Timeline
8 May 2019
Primary endpoint
4 August 2019
4 August 2019

Quick facts

Lead sponsorSeagen Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment36
Start date8 May 2019
Primary completion4 August 2019
Estimated completion4 August 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other trials of Tucatinib

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Seagen Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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