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

Completed · Phase 2

Conditions studied: Tuberculosis

In brief

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.

Key facts

Study ID

NCT03891901

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Starts

2020-10-27

Expected to finish

2022-08-30

Last updated by the study team

2023-10-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult age between 18 years and 55 years
• Body mass index (BMI) greater than 18.5 kg/m\^2
• At least 8 years formal education, with appropriate reading and comprehension skills
• Able and willing to provide written informed consent
• Males must agree to using contraception during the study and for 2 weeks after the last dose of study drug.
• If a female participant is of reproductive potential, the participant (and her partner) must agree to use of one of the following combinations of birth control during the study and for 2 weeks after the last dose of study drug (or tubal ligation as a single method):
• Use of a double-barrier method of contraception: condoms (male or female) and a diaphragm or cervical cap with spermicide;
• Use of an intrauterine device (IUD) and a barrier method: condoms (male or female, with or without spermicide) or a diaphragm or cervical cap with spermicide;
• For those in the imatinib only study arms: use of hormone-based contraceptives (pill, patch, implant, ring, or injectable) and a barrier method: condoms (male or female, with or without spermicide) or a diaphragm or cervical cap with spermicide (participants in study arms receiving isoniazid and rifabutin are not eligible if they are relying hormonal contraceptives other than an IUD)
• Tubal ligation.
• Women who are post-menopausal, defined as age greater than 45 and no menses for at least 1 year, or who have had a hysterectomy, are considered not of reproductive potential.

You may not qualify if…

• Current or imminent treatment for significant infection
• Pregnant or breastfeeding
• HIV positive status as determined by a U.S. Food and Drug Administration (FDA)-approved HIV assay
• Hepatitis B infection, as determined by an FDA-approved hepatitis B surface antigen assay
• Hepatitis C infection, as determined by an FDA-approved positive Hepatitis C antibody assay
• Known infection with Mycobacterium tuberculosis (MTB)
• History of allergy or hypersensitivity to imatinib, isoniazid or rifabutin.
• History of enrollment in other clinical trials with investigational agents within 8 weeks
• Cardiac arrhythmia requiring medication, or any clinically significant electrocardiogram (ECG) abnormality
• Exam consistent with congestive heart failure (e.g., edema)
• Random blood glucose greater than 140 mg/dL or history of unstable diabetes mellitus requiring hospitalization for hyper or hypoglycemia within the past year prior to start of screening
• Use of systemic corticosteroids within the past 28 days
• Any of the following readings from a complete blood count that fall outside the normal ranges as listed here:
• White blood cell count: 3.4 10E3/microliter (mcL) - 11 10E3/mcL
• Hemoglobin: Female- 11.1 - 16.7 gm/dL, Male- 12.5 - 16.5 gm/dL
• Platelet count: 150-400 10E3/mcL
• Absolute neutrophil count: Female- 0.91-5.53 10E3/mcL, Male- 0.67-6.41 10E3/mcL
• Absolute lymphocyte count: Female- 0.65-3.05 10E3/mcL, Male- 0.72-3.29 10E3/mcL
• Any of the following chemistry panel and liver function test readings that fall outside the normal ranges as listed here:
• Serum potassium: 3.5-5.4 mmol/L
• Alkaline phosphatase (ALP): 34 - 104 unit/L
• Alanine aminotransferase (ALT): 4 - 52 unit/L
• Aspartate aminotransferase (AST): 13 - 39 unit/L
• Total Bilirubin: 0.2 - 1.0 mg/dL
• Creatinine: Female- 0.60-1.20 mg/dL, Male- 0.7-1.3mg/dL

Where it is running

• Emory University DAIDS TB Non-Network CRS — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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