A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)

Official title

A Phase 1, Single-center, Open-Label, Randomized, Three-Period, Six-Sequence, Single-Dose, Crossover Study in Healthy Participants Under Fasted or Fed Condition to Compare the Relative Bioavailability of Orally Administrated Octreotide Acetate Tablets (T25) and Orally Administrated Octreotide Acetate Delayed-Release Capsules (MYCAPSSA®) and to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25

Overview

The goal of this clinical trial\] is to to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25 in healthy volunteers. The main questions it aims to answer are： 1. How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa？ 2. What effects does of food have on the pharmacokinetic profile of T25 when administerted under high fat diet? Participants will: Take T25 under both fast and food state or mycapssa in under fast state in Day1, Day4, and Day7, 13. A follow-up visit is scheduled on D14+(7), which is 7\~14 days after the last dose of investigational product via phone/message/WeChat or in face-to-face manner.

Interventions

• Drug T25-Fast
  Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state
• Drug Mycapssa
  Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state
• Drug T25-Fed
  Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state

Primary outcome measures

• bioavailability [Time frame: From time 0 (administration) to 24 hours post-administration]
• bioavailability [Time frame: From time 0 (administration) to 24 hours post-administration.]
• bioavailability [Time frame: From 0 (administration) to 24hour]
• bioavailability [Time frame: From time 0 (administration) to 24 hours post-administration]
• bioavailability [Time frame: From time 0 (administration) to 24 hours post-administration.]
• bioavailability [Time frame: From time 0 (administration) to 24hour.]

Secondary outcome measures (12)

• PK profile (Tlag) [Time frame: From time 0 (administration) to 24 hours post-administration]
• PK profile(Tmax) [Time frame: From time 0 (administration) to 24 hours post-administration]
• PK profile(t₁/₂) [Time frame: From time 0 (administration) to 24 hours post-administration]
• PK profile(Kel) [Time frame: From time 0 (administration) to 24 hours post-administration]
• PK profile(CL/F) [Time frame: From time 0 (administration) to 24 hours post-administration]
• PK profile(Vz/F) [Time frame: From time 0 (administration) to 24 hours post-administration]
• PK profile(AUC_%Extrap) [Time frame: From time 0 (administration) to 24 hours post-administration]
• the gastrointestinal transit of T25 using an abdominal X-ray [Time frame: Administration of T25 under fasted condition: the abdominal X-ray will be taken at 0.75 hour, 1.5 hour, 2.0 hour, 3.0 hour, 4.0 hour post-dose.]
• the gastrointestinal transit of T25 using an abdominal X-ray [Time frame: Administration of T25 under fed condition: the abdominal X-ray will be taken at 2.0 hour, 3.0 hour, 4.5 hour, 6.0 hour, 8.0hour post-dose.]
• Safety and tolerability - number and severity of adverse events [Time frame: From the first dose until 7 days after the last dose]
• Safety and tolerability -Temperature (ear) [Time frame: From the first dose until 7 days after the last dose]
• Safety and tolerability - Blood pressure [Time frame: From the first dose until 7 days after the last dose]

Eligibility criteria

Inclusion criteria

• Healthy male or female aged 18 to 55 years (both inclusive).
• Participants with a body mass index (BMI, weight \[kg\]/height2 \[m2\]) within 19-28 kg/m2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female.
• Participants with good physical condition, without any history of disease or clinically relevantly abnormal vital signs or physical examination. Participants in good general health, without clinically significant physical examination, vital signs, laboratory tests, ECGs, or abdominal ultrasound findings at Screening or Check-in (Day -2) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
• Participants with childbearing potential must agree to use adequate contraception and have no plan for pregnancy from screening period throughout 3 months after the last dose of investigational product; Women of childbearing potential (WOCBP) must have a negative blood pregnancy test prior to the first dose of investigational products. Note: WOCBP are defined as females who have reached menarche but have not yet undergone menopause (defined as ≥12 consecutive months of amenorrhea for non-pathological reasons) and have not undergone surgical sterilization (removal of ovaries and/or uterus).
• Participants must fully understand and voluntarily sign the informed consent form prior to the initiation of any study procedures.
• Participants with high compliance for all protocol requirements.

Exclusion criteria

• Participants with allergic disease or allergic to investigational products or its excipients, or more than two kinds of medications, food, or beverage.
• Participants with positive for human immunodeficiency virus (HIV) antibody test; active infection with Hepatitis B, C; positive treponema pallidum antibody test.
• Participants with a history of chronic or severe diseases involving the cardiovascular, hepatic, renal, gall biliary, respiratory, hematologic/lymphatic, endocrine, immune, psychiatric, neuromuscular, or GI systems from one year prior to the first dose of study drug; or with a history (or a current condition) of GI disorders during this period, such as chronic or active upper GI diseases (e.g., esophageal disorders, gastritis, duodenitis, peptic ulcers), active GI bleeding, or history of GI surgery, as determined by the Investigator, may impact the ability of the subject to participate or potentially confound the study results.
• Participants who have received a radiation dose exceeding 5 mSv within the past 12 months (e.g., more than 2 cranial CT scans \[approximately 2 mSv per scan\], more than 3 low-dose chest CT scans \[approximately 1.5 mSv per scan\], more than 1 standard chest CT scan \[4-7 mSv per scan\], or more than 1 abdominal CT scan \[8 mSv per scan\]), or have received a total radiation dose over 10 mSv in the preceding 5 years, or are scheduled to undergo additional radiological examinations during the trial or within one year after the completion of the trial.
• AST > ULN or bilirubin > ULN.
• Creatinine clearance <90 mL/min during screening (calculation formula of Creatinine Clearance is detailed in Section 8.2.1.6).
• Participants with a history or presence of hypothyroidism.
• Participants with a history of drug abuse within 5 years or intake of any narcotics within 6 months before the initial administration, or who have a positive drug abuse test on admission.
• Participants with a history of alcohol abuse within 6 months before the initial administration, defined as an average alcohol intake > 2 units/day (1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine).
• Participants with a history of smoking > 5 cigarettes/day within 3 months before the initial administration or unable to refrain from using any tobacco or nicotine-containing product within 48 hours prior to administration and during hospitalization.
• Participants who have donated or lost blood > 400 mL within 3 months before the initial administration.
• Participants who have received major surgery or hospitalized within 3 months before the initial administration.
• Participants who have received investigational drugs or participated in other clinical trials within 3 months before the initial administration.
• Participants who have received prescription drug within 14 days before the initial administration.
• Participants who have taken high-density medications such as bismuth agents and calcium agents within 7 days before the initial administration.
• Participants who have received over the counter (OTC) drug or herb within 7 days before the initial administration.
• Participants who have consumed grapefruit juice, or other food or beverage containing caffeine or xanthine within 7 days before the initial administration.
• Participants who have drunk alcohol within 48 hours before the initial administration or with a positive breath alcohol test (> 0 mg/100 mL).
• Participants cannot receive standard meals during the study.
• Participants who cannot tolerate venipuncture or have a history of fear of needles or hemophobia.
• Participants with vitamin B12 deficiency.
• Participants with acute minor diseases (common cold, diarrhea, etc.) during screening.
• For female participants, breastfeeding or positive for pregnancy test at screening, or who have unprotected sexual contact within 2 weeks before dosing, or who have intrauterine devices in their bodies.
• Participants who are not suitable for participating in this study due to other reasons as judged by Investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07663318 · T25-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗