Healthy Volunteers Clinical Trial
Official title:
Explore the Synergy of Combination TKI Therapy - A Pilot Study to Evaluate the Effect of Imatinib on Dasatinib Pharmacokinetics in Healthy Volunteers
This research study is looking at how imatinib affects how dasatinib is absorbed and eliminated from the body. Both imatinib and dasatinib are in a class of medications called tyrosine kinase inhibitors (TKI) and they are used to treat certain types of leukemia (cancer that begins in the white blood cells). Both imatinib and dasatinib have been given safely in healthy volunteers. In this study investigators will evaluate the pharmacokinetics interaction between imatinib and dasatinib when they are co-administered. The hypothesis is that imatinib will increase the blood levels of dasatinib through inhibiting the drug metabolizing enzyme and efflux transporter that are involved in the dasatinib absorption and removal. This research will provide important new insight of combination TKI therapy in terms of transporter- and enzyme- mediated pharmacokinetic interactions. The research results will also help guide doctors in knowing how much of a tyrosine kinase inhibitor to give safely while reaching best effect in TKI combination therapy.
If the subjects qualify to take part in this research study, they will undergo the following
procedures.
Subjects will be asked to abstain from alcoholic beverages (24 hours), grapefruit products,
herbal supplements/teas, and over-the-counter medications (48 hours) prior to the study
visits. There will be two study periods in this study. During each period all the subjects
are outpatients and there will be no overnight stay. During each study period, the subjects
will come to the University of Florida Clinical Research Center (UF CRC) three times: on Day
-1, Day 1, and Day 2, respectively. Subjects will report to the UF CRC the day before Day 1
(i.e. Day -1) to have clinical lab test and urine pregnancy test (female only). Subjects
will come to UF CRC at 6:30 a.m. on Day 1 and Day 2 of each study visit. During the morning
of each study period (around 8:30 am) subjects will be randomly assigned to receive a single
oral dose of dasatinib 20 mg either with or without a single oral dose of imatinib 400 mg
administered one hour prior to dasatinib. After the first study visit, the subjects will
return one to two weeks later for the second study visit, receiving the opposite treatment.
The treatment order for the study visits will be assigned randomly. The end point measures
for this study are plasma concentrations of dasatinib. A total of twelve (12) blood samples
will be collected for a total amount of 84 ml (about 3 ounces or about 6 tablespoonsful) for
each subject during each study period.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |