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A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants

NCT04981704 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2021-09-05

No results posted yet for this study

Summary

The purpose of the study is to evaluate the effect of multiple-doses of itraconazole, phenytoin and paroxetine on the single-dose pharmacokinetics (PK) of poziotinib in healthy adult participants.

Conditions

  • Healthy

Interventions

DRUG

Poziotinib

Poziotinib Tablets

DRUG

Itraconazole

Itraconazole Oral solution

DRUG

Phenytoin

Phenytoin Capsules

DRUG

Paroxetine

Paroxetine Tablets

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Shanta Chawla, MD · Spectrum Pharmaceuticals, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2021-06-30
Completion
2021-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04981704 on ClinicalTrials.gov