MyelofibrosesPhase 1NCT07492355
TP-3654 Food Effect Study
A Phase 1 study testing TP-3654 in people with Myelofibroses, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
This clinical trial will determine the bioavailability and effect of food on TP-3654 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myelofibroses
- What is being tested?
- TP-3654
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 31 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myelofibroses
- Being tested
- TP-3654
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP-3654Drug
capsule, oral administered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: TP-3654 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 13 days
Secondary outcomes (1)
The number of adverse events and their severity as reported in healthy adult participants
Measured: 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start4 Mar 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492355
- Sponsor's protocol ID
- TP-3654-104
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized Study in Healthy Adult Participants to Assess the Relative Bioavailability of and Effect of Food on TP-3654 Capsule Formulations
- ClinicalTrials.gov ID
- NCT07492355
- Acronym / sponsor ID
- TP-3654-104
- Conditions
- Myelofibroses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will determine the bioavailability and effect of food on TP-3654 in healthy adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: TP-3654Randomized, 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. |
| Part B | Experimental | Drug: TP-3654Randomized, 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TP-3654capsule, oral administered | Drug | Part A, Part B |
Primary outcome
The Cmax for relative bioavailability of TP-3654 in Part A
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
The number of adverse events and their severity as reported in healthy adult participants
Time frame: 47 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TP-3654 in people with Myelofibroses, run by Sumitomo Pharma America, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cmax for relative bioavailability of TP-3654 in Part A (time frame: 13 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.