Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Part of paid clinical trials in Miami, Florida.

Sponsor
Daiichi Sankyo
Study ID
NCT06740799
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Quizartinib — DRUG
    Participants will receive a single oral dose of 30 mg

Study Details

This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.

Key Dates

Start date
Sep 30, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Severe HI
    Participants will receive a single oral dose of 30 mg quizartinib
  • Experimental: Control Group
    Healthy participants will receive a single oral dose of 30 mg quizartinib

Primary Outcome Measure

Pharmacokinetic Parameter: Cmax [ Time Frame: From day of first dose, Day 1, through Day 29 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Advanced PharmaMiamiFlorida33147-
Clinical Pharmacology of Miami, LLCMiamiFlorida33014-
GCP ResearchSt. PetersburgFlorida33705-

Find similar trials in Miami, FL

By research site
Advanced Pharma· Miami, FLClinical Pharmacology of Miami, LLC· Miami, FLGCP Research· St. Petersburg, FL

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