Myelofibroses
Conditions
Brief summary
This clinical trial will determine the bioavailability and effect of food on TP-3654 in healthy adult participants.
Interventions
DRUGTP-3654
capsule, oral administered
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant has a BMI ≥ 18.5 and ≤ 32 kg/m2 at screening. * Participant is generally healthy, as determined by the Investigator based on medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG at screening. * Participant agrees to avoid the use of concomitant medications (except hormonal contraception or medication provided by the site staff under the direction of the Investigator) from time of screening through the final follow-up visit. * Participant agrees to abstain from alcohol, recreational drugs (including marijuana), and nicotine from time of screening through the final follow-up visit. * Participant agrees to use acceptable method of contraception during the duration of the study and up to 6 months after last dose. * Participant agrees to not donate eggs or sperm during the study and up to 6 months after last dose.
Exclusion criteria
* Pregnancy * History of alcohol and recreational drug use including smoking and/or use of nicotine products. * Clinically significant medical history * Exposure to other investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Cmax for relative bioavailability of TP-3654 in Part A | 13 days | Analysis of the maximum concentration (Cmax) of the relative bioavailability of TP-3654 in two different capsule formulations utilizing the ratio of adjusted geometric means |
| The Cmax for relative bioavailability of TP-3654 in Part B | 13 days | Analysis of the maximum concentration (Cmax) of the relative bioavailability of the selected capsule formulation of TP-3654 from Part A when administered in fed versus fasting conditions utilizing the ratio of adjusted geometric means. |
| The AUC for relative bioavailability of TP-3654 in Part A | 13 days | Analysis of the area under the concentration (AUC) time curve of the relative bioavailability of TP-3654 in two different capsule formulations utilizing the ratio of adjusted geometric means |
| The AUC for relative bioavailability of TP-3654 in Part B | 13 days | Analysis of the area under the concentration (AUC) time curve of the relative bioavailability of the selected capsule formulation of TP-3654 from Part A when administered in fed versus fasting conditions utilizing the ratio of adjusted geometric means. |
Secondary
| Measure | Time frame |
|---|---|
| The number of adverse events and their severity as reported in healthy adult participants | 47 days |
Countries
United States
Outcome results
None listed