Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654

Completed · Phase 1

Conditions studied: Healthy

In brief

This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70% of the capsule formulation.

Key facts

Study ID

NCT06389955

Run by

Sumitomo Pharma America, Inc.

People needed

12

Starts

2023-05-22

Expected to finish

2023-08-24

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant has provided written informed consent.
• Participant is ≥ 18 to ≤ 65 years of age.
• Participant is willing and able to consume the prescribed standard meals.
• Participant agrees to use an acceptable method of contraception as described in Section 8.5.4 for the duration of the study and agrees to continue use for 3 months after the final dose (male participants) or for 6 months after the final dose (female participants).
• Male participant agrees not to donate sperm during the study and for 3 months after the last dose of study drug. Female participant agrees not to donate eggs for the duration of the study and for 6 months after the last dose of study drug.
• 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 electrocardiogram (ECG) at screening. In particular:
• Clinical laboratory results must be within normal range
• Body temperature is < 38°C (100.3°F).
• Blood pressure and heart rate are within normal limits (systolic blood pressure is ≥ 90 to ≤ 150 mmHg; supine diastolic blood pressure is ≥ 50 to ≤ 90 mmHg; heart rate is ≥ 40 to ≤ 90 bpm) at screening.
• Average triplicate corrected QT interval (QTcF) ≤ 430 msec (for male participants) or ≤ 450 msec (for female participants).
• 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 screening through the final follow-up visit.
• Participant agrees to abstain from alcohol, recreational drugs (including marijuana), and nicotine from screening through the final follow-up visit.
• Participant is willing and able to remain confined in the Clinical Research Unit for the duration of the inpatient period (13 days for Part A or 10 days for Part B)

You may not qualify if…

• Participant is pregnant (as evidenced by a positive pregnancy test) or nursing.
• Participant reports a history (within 3 years prior to screening) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other disorders as determined by the Investigator.
• Participant reports use of CYP3A hepatic microsomal enzyme interacting drugs (such as voriconazole, fluconazole, cimetidine) within 30 days prior to admission.
• Participant reports being exposed to an investigational product (drug, biologic, or device) within 30 days preceding the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
• Participant reports having a surgical procedure that may affect drug absorption, distribution, metabolism, and/or excretion (eg, bariatric procedure, cholecystectomy). Appendectomy is acceptable.
• Participant reports donating blood within 8 weeks before the first dose administration.
• Participant reports a history of alcohol or drug use disorder within 2 years before screening.
• Participant has a positive drug screening test reflecting use of recreational drugs.
• Participant reports being a current smoker or use of nicotine products (eg, nicotine gum or patch, vaporized nicotine, chewing tobacco)
• Participant has poor venous access or has a history of difficulty providing blood samples.
• Participant reports any condition or has any finding that would, in the Investigator's opinion, put the participant or study conduct at risk if the participant were to be enrolled in the study.

Where it is running

• Frontage Investigative Site — Secaucus, New Jersey, United States

Full record on ClinicalTrials.gov

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