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Completed

NCT Number: NCT07492355

TP-3654 Food Effect Study

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Frontage Clinical

Secaucus, New Jersey, 07094, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TP-3654

Drug

capsule, oral administered

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

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

    Time frame: 47 days

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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