TP-3654 Food Effect Study

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Myelofibroses

Treatments: Drug: TP-3654

Study type: Interventional

Funder types: Industry

Identifiers

NCT07492355

TP-3654-104

Details and patient eligibility

About

This clinical trial will determine the bioavailability and effect of food on TP-3654 in healthy adult participants.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Part A

Experimental group

Description:

Randomized, single-dose, 3-period, 3-way cross-over study to assess the relative bioavailability of TP-3654 capsule formulation (1:5 ratio of API:excipient) vs capsule formulations using a 1:3 and 1:2 of API:excipient ratio.

Treatment:

Drug: TP-3654

Part B

Experimental group

Description:

Randomized, single-dose, 3-period, 3-way cross-over study to evaluate the effect of food on the PK of the Sponsor's selected TP-3654 capsule formulation (1:3 or 1:2).

Treatment:

Drug: TP-3654