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Pacritinib Drug Interactions Study
Study Summary
This trial tests drug interactions in people. Each person takes part in one part of the trial.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- You have a history or currently have a significant health issue related to your respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic, or dermatological/connective tissue system.You have a history or ongoing condition that affects your heart, lungs, liver, kidneys, blood, stomach, metabolism, allergies, skin, brain, or mental health. Recent appendectomy or cholecystectomy (3-6 months ago) are not considered as an exclusion factor.You have had bleeding in your stomach or intestines in the past.Your genotype testing for CYP2C19 *1/*1 indicates that you are a normal metabolizer.You must have easy access to your veins for blood samples to be taken.You agree to follow all the rules outlined in the study.You have smoked or used nicotine products, such as gum or patches, within the past 6 months.You have a history of allergies to certain medications or food, such as digoxin, caffeine, and omeprazole. You have also had an allergic reaction to phenytoin or carbamazepine if you are in Group B.You have been sick with a significant illness, including a virus, within the last 3 weeks.You have a history of heart problems, fainting, or are at risk for a certain type of irregular heart rhythm called torsades de pointes.You have a serious medical condition related to allergy, blood, hormones, lungs, digestion, heart, liver, mind, or nerves. However, if you have a mild joint disease unrelated to a serious condition, you may still be considered if approved by the medical monitor.You cannot take medication by mouth.Someone in your family has died suddenly from a heart problem that was not caused by a heart attack.You have eaten pomegranate or pomelo fruit or consumed their juice, or had alcohol within 72 hours before the check-in on Day -1.You are a male between the ages of 18 and 55 during the initial screening.You have had cancer in the past, such as lymphoma or leukemia.You are able to understand and sign a document that explains the study and your participation in it.Your body mass index (BMI) must be between 18.0 to 32.0 kg/m2 during screening.Your heart rate is too slow or too fast, or your body temperature is too low or too high when measured during screening.You are within a healthy weight range based on your height, with a body mass index (BMI) between 18 and 32.You have normal kidney function with an eGFR of 90 mL/min or higher.You are healthy according to your medical history, lab results, vital signs, ECG, and physical exam at the time of screening.Male participants must use approved methods of contraception or abstain from sexual activity for 90 days after the end of the study. They must also not donate sperm during this time.
- Group 1: CYP450 3A4 inducer (Bosentan) with Pacritinib
- Group 2: CYP450 Cocktail and Transporter Substrates with Pacritinib
- Group 3: CYP450 3A4 inhibitor (Fluconazole) with Pacritinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age criterion for this trial restricted to participants below 35 years old?
"As per the parameters of this study, only individuals aged 18-55 will be considered for enrollment."
Might individuals be adversely affected by participating in Part 2 Group B?
"Limited clinical data exists to vouch for the safety and efficacy of Part 2 Group B, earning it a score of 1."
Is recruitment for the research study ongoing?
"Affirmative, the clinicaltrial.gov page confirms that this study is still actively recruiting participants. It was first added to the database on March 1st 2023 and last updated January 13th of the same year. 54 patients are needed from a single trial site."
What is the upper limit of individuals who are undergoing this clinical trial?
"Indeed, according to the records on clinicaltrials.gov this medical study is currently accepting participants for enrollment. The trial was initially posted on March 1st 2023 and has since been updated as recently as January 13th 2023. 54 patients are needed from a single location to complete the experiment."
What primary purpose is this clinical trial designed to fulfill?
"According to the research sponsor, CTI BioPharma, the primary outcome that will be monitored over a 14 day period is Change in area under curve (AUC) of pacritinib alone and pacritinib + bosentan administration. Secondary outcomes include Number and severity of adverse events with pacritinib in the presence of CYP450 3A4 inducer as well as CYP450 3A4 inhibitor; plus safety and tolerability assessments when co-administered with fluconazole, digoxin, caffeine, midazolam, omeprazole, rosuvastatin or metform"
May I be considered for participation in this clinical trial?
"This trial is recruiting 54 individuals aged 18-55, with existing drug interaction issues. These applicants must have the following attributes: a BMI of 18 to 32 kg/m2; normal renal function >90 mL/min eGFR; good overall health according to medical history and physical exam results at screening; CYP2C19 *1/*1 genotype for identifying metabolizers; male participants using contraception or abstaining from intercourse during the study period (or female partner); adequate venous access for blood draws and agreement to comply with all protocol requirements. Participation also requires written informed consent."
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