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

NCT ID: NCT03723395

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2018-12-28

Brief Summary

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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.

Detailed Description

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This is a fixed-sequence, drug-drug interaction study of tucatinib conducted in 5 parts in healthy subjects. Part A will evaluate the effect of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics (PK) of tucatinib. Part B will evaluate the effect of rifampin, a strong inducer of CYP3A4 and CYP2C8, on the PK of tucatinib. Part C will evaluate the effect of the strong CYP2C8 inhibitor gemfibrozil on the PK of tucatinib. Part D will evaluate the effects of tucatinib on the PK of substrate probes of the metabolizing enzymes CYP2C8 (repaglinide), CYP2C9 (tolbutamide), and CYP3A4 (midazolam). Part E will evaluate the effect of tucatinib on the PK of a substrate probe of the transporter P-gp (digoxin). Parts A, B, C, D, and E of the study are independent of one another and do not need to be conducted in a particular order.

Conditions

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Drug-drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A

Tucatinib plus Itraconazole

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

300mg dose, orally administered

itraconazole

Intervention Type DRUG

200mg dose

Part B

Tucatinib plus Rifampin

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

300mg dose, orally administered

rifampin

Intervention Type DRUG

600mg dose

Part C

Tucatinib plus Gemfibrozil

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

300mg dose, orally administered

gemfibrozil

Intervention Type DRUG

600mg tablets

Part D

Tucatinib plus Repaglinide plus Tolbutamide plus Midazolam

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

300mg dose, orally administered

repaglinide

Intervention Type DRUG

1mg dose

tolbutamide

Intervention Type DRUG

500mg dose

midazolam

Intervention Type DRUG

2mg dose

Part E

Tucatinib plus Digoxin

Group Type EXPERIMENTAL

tucatinib

Intervention Type DRUG

300mg dose, orally administered

digoxin

Intervention Type DRUG

0.5 mg dose

Interventions

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tucatinib

300mg dose, orally administered

Intervention Type DRUG

itraconazole

200mg dose

Intervention Type DRUG

rifampin

600mg dose

Intervention Type DRUG

gemfibrozil

600mg tablets

Intervention Type DRUG

repaglinide

1mg dose

Intervention Type DRUG

tolbutamide

500mg dose

Intervention Type DRUG

midazolam

2mg dose

Intervention Type DRUG

digoxin

0.5 mg dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) between 18 and 32 kg/m\^2
* In good health, determined be no clinically significant findings from medical history, physical examination, and screening evaluations
* Female subjects must be of nonchildbearing potential
* Male subjects must agree to use contraception or must be surgically sterile for at least 90 days prior to enrollment
* Able to understand and sign informed consent form

Exclusion Criteria

* Any condition affecting drug absorption (including stomach or intestinal surgery)
* Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of hypersensitivity, intolerance, or allergy to any drug compounds, food, or other substance (unless approved by Investigator)
* Participation in a clinical study involving an investigational drug within the past 30 days
* Use or intend to any prescription medications within 28 days prior to check in
* Use of tobacco- or nicotine-containing products within 28 days prior to check in
* History of hyperbilirubinemia
* History of alcoholism or drug abuse within 2 years
* History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects
* Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Vo, PhD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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Covance Clinical Research Unit

Daytona Beach, Florida, United States

Site Status

Covance Clinical Research Unit

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Zhang D, Taylor A, Zhao JJ, Endres CJ, Topletz-Erickson A. Population Pharmacokinetic Analysis of Tucatinib in Healthy Participants and Patients with Breast Cancer or Colorectal Cancer. Clin Pharmacokinet. 2024 Oct;63(10):1477-1487. doi: 10.1007/s40262-024-01412-0. Epub 2024 Oct 5.

Reference Type DERIVED
PMID: 39368039 (View on PubMed)

Topletz-Erickson A, Lee A, Rustia EL, Sun H, Mayor JG, Abdulrasool LI, Walker L, Endres CJ. Evaluation of Safety and Clinically Relevant Drug-Drug Interactions with Tucatinib in Healthy Volunteers. Clin Pharmacokinet. 2022 Oct;61(10):1417-1426. doi: 10.1007/s40262-022-01144-z. Epub 2022 Aug 6.

Reference Type DERIVED
PMID: 35931943 (View on PubMed)

Other Identifiers

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ONT-380-012

Identifier Type: -

Identifier Source: org_study_id