TP-3654 Food Effect Study

A Phase 1 Randomized Study in Healthy Adult Participants to Assess the Relative Bioavailability of and Effect of Food on TP-3654 Capsule Formulations

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

Study Overview

• Status: Completed
• Conditions: Myelofibroses
• Intervention / Treatment: Drug: TP-3654

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Secaucus, New Jersey, United States, 07094
      • Frontage Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; 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; capsule, oral administered
Experimental: Part B; 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; capsule, oral administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The number of adverse events and their severity as reported in healthy adult participants	47 days

Collaborators and Investigators

• Sponsor: Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Hemic and Lymphatic Diseases; Primary Myelofibrosis; TP 3654
• Other Study ID Numbers: TP-3654-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No