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PK of Pacritinib in Patients With Mild, Moderate, Severe Renal Impairment and ESRD Compared to Healthy Subjects

NCT02807077 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-10-22

No results posted yet for this study

Summary

This is a Phase 1 open label, single dose, 5 parallel-group study in which a single 400 mg dose of pacritinib will be administered orally to patients with renal impairment (mild, moderate, severe, and patients with ESRD requiring hemodialysis) and sex-, age- and weight-matched healthy subjects.Patients with ESRD will receive a single 400 mg dose of pacritinib during 2 different treatment periods: Dialysis and Inter-Dialysis. The primary objective of the study is to evaluate the pharmacokinetics and safety of pacritinib in renal impairment.

Conditions

Interventions

DRUG

Pacritinib

Group 1, 2, 3, and 5 will be administered single oral 400-mg dose of pacritinib. Subjects in the Group 4 received a single 400-mg dose of pacritinib during two different treatment periods: Dialysis and Inter-Dialysis

Sponsors & Collaborators

  • SGS S.A.

    collaborator INDUSTRY

  • CTI BioPharma

    lead INDUSTRY

Principal Investigators

  • Igor Codreanu, MD · Republican Clinical Hospital

  • Gernot Klein, MD · APEX GmbH

  • Mircea N Penescu, MD · Carol Davila Nephrology Hospital Bucharest

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Germany
  • Moldova
  • Romania

Study Locations

More Related Trials

Entities

Diseases

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 NCT02807077 on ClinicalTrials.gov