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A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib

NCT03723395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-12-18

No results posted yet for this study

Summary

This study is being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C are looking at how the body breaks down tucatinib when there are lower levels of certain liver enzymes. Part B is looking at how the body breaks down tucatinib when there are high levels of certain liver and stomach enzymes. Parts D and E are looking at how tucatinib could change the levels of some liver and stomach enzymes in the body. This will help us know more about how tucatinib should be given to patients.

Conditions

  • Drug-drug Interaction

Interventions

DRUG

tucatinib

300mg dose, orally administered

DRUG

itraconazole

200mg dose

DRUG

rifampin

600mg dose

DRUG

gemfibrozil

600mg tablets

DRUG

repaglinide

1mg dose

DRUG

tolbutamide

500mg dose

DRUG

midazolam

2mg dose

DRUG

digoxin

0.5 mg dose

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Alex Vo, PhD · Seagen Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2018-12-21
Completion
2018-12-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723395 on ClinicalTrials.gov