TP-3654 Food Effect Study

NCT07492355 | Completed Phase 1 FDA Drug

• 1 other identifier: TP-3654-104
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myelofibroses

Outcome Measures

Primary Outcomes (4)

• The Cmax for relative bioavailability of TP-3654 in Part A

  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

  13 days

• The Cmax for relative bioavailability of TP-3654 in Part B

  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.

  13 days

• The AUC for relative bioavailability of TP-3654 in Part A

  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

  13 days

• The AUC for relative bioavailability of TP-3654 in Part B

  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.

  13 days

Secondary Outcomes (1)

• The number of adverse events and their severity as reported in healthy adult participants

  47 days

Study Arms (2)

Part A

EXPERIMENTAL

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.

Drug: TP-3654

Part B

EXPERIMENTAL

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).

Drug: TP-3654

Interventions

TP-3654 DRUG

capsule, oral administered

Part A; Part B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: male, female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (1)

Frontage Clinical

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

TP 3654

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: March 4, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)