Clinical trial NCT06389955: Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654
Official title: A Phase 1, Randomized, Study in Healthy Volunteers to Assess Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Part A is a randomized, single-dose, 4-period, 4-way cross-over study to evaluate the effect of food on the TP 3654 capsule and assess the relative bioavailability of the TP-3654 capsule versus tablet formulations. Following a screening period of up to 28 days, eligible participants will be admitted to the clinical research unit (CRU) on Day -1. Participants will fast overnight from Day -1 to Day 1. On Day 1, participants will be randomly assigned to a treatment sequence, and they will receive TP-3654 per their assigned sequence.

Part B is a randomized, single-dose, 3-period, 3-way cross-over study to evaluate the effect of food on the PK of the TP-3654 tablet formulation. Following a screening period of up to 28 days, eligible participants will be admitted to the CRU on Day -1. As with Part A, participants will fast overnight from Day -1 to Day 1. On Day 1, they will be randomly assigned to a treatment sequence, and they will receive TP-3654 per their assigned sequence.

Eligibility criteria: Inclusion Criteria:

1. Participant has provided written informed consent.
2. Participant is ≥ 18 to ≤ 65 years of age.
3. Participant is willing and able to consume the prescribed standard meals.
4. 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).
5. 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.
6. Participant has a BMI ≥ 18.5 and ≤ 32 kg/m2 at screening.
7. 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:

   1. Clinical laboratory results must be within normal range
   2. Body temperature is \< 38°C (100.3°F).
   3. 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.
   4. Average triplicate corrected QT interval (QTcF) ≤ 430 msec (for male participants) or ≤ 450 msec (for female participants).
8. 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.
9. Participant agrees to abstain from alcohol, recreational drugs (including marijuana), and nicotine from screening through the final follow-up visit.
10. 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)

Exclusion Criteria:

1. Participant is pregnant (as evidenced by a positive pregnancy test) or nursing.
2. 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.
3. Participant reports use of CYP3A hepatic microsomal enzyme interacting drugs (such as voriconazole, fluconazole, cimetidine) within 30 days prior to admission.
4. 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).
5. Participant reports having a surgical procedure that may affect drug absorption, distribution, metabolism, and/or excretion (eg, bariatric procedure, cholecystectomy). Appendectomy is acceptable.
6. Participant reports donating blood within 8 weeks before the first dose administration.
7. Participant reports a history of alcohol or drug use disorder within 2 years before screening.
8. Participant has a positive drug screening test reflecting use of recreational drugs.
9. Participant reports being a current smoker or use of nicotine products (eg, nicotine gum or patch, vaporized nicotine, chewing tobacco)
10. Participant has poor venous access or has a history of difficulty providing blood samples.
11. 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.

Primary outcomes:
measure: Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation
timeFrame: 2 weeks
measure: Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation
timeFrame: 2 weeks
measure: Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions
timeFrame: 2 weeks
measure: Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of participants with Treatment Emergent Adverse Events (TEAE)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: Frontage Investigative Site
state: New Jersey
Study officials:
References: