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PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

NCT04887194 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-08

No results posted yet for this study

Summary

Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

Sitravatinib

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

DRUG

Warfarin

CYP2C9 probe substrate

DRUG

Dextromethorphan

CYP2D6 probe substrate

DRUG

Midazolam

CYP3A4 probe substrate

DRUG

Digoxin

P-gp probe substrate

DRUG

Rosuvastatin

BCRP probe substrate

DRUG

Nivolumab

Nivolumab is a programmed death receptor (PD-1) blocking antibody

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Curtis Chin, MD · Mirati Therapeutics Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2022-12-22
Completion
2022-12-22
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 NCT04887194 on ClinicalTrials.gov