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A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin

NCT03891901 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-23

Study results available
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Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin. The results of this trial will determine the imatinib dose to be studied in a subsequent Phase IIB treatment trial of imatinib as an adjunctive therapy with an antimicrobial regimen (rifabutin, pyrazinamide (PZA), isoniazid (INH) and ethambutol) for drug-sensitive TB.

Conditions

Interventions

DRUG

Imatinib

Tablets, administered orally

DRUG

Isoniazid

300 mg tablets, administered orally

DRUG

Rifabutin

300 mg capsules, administered orally

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • Aurum Institute

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Edmund K. Waller, MD, PhD, FACP · Emory University School of Medicine, Winship Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2022-08-30
Completion
2022-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT03891901 on ClinicalTrials.gov