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)

NCT07663318 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: T25-101
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa？
2. 2.What effects does of food have on the pharmacokinetic profile of T25 when administerted under high fat diet?

Conditions

Acromegaly

Keywords

Octreotide

Outcome Measures

Primary Outcomes (6)

• bioavailability

  The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax)

  From time 0 (administration) to 24 hours post-administration

• bioavailability

  The ratio of geometric least square means between the T25 and MYCAPSSA® for area under the concentration-time curve (AUC) from time zero to the last time point with a measurable concentration (AUC0-tlast) . Sampling (Fasted condition) occurs at the following timepoints: 0 (pre-dose) , 0.5 , 1.0, 1.33 , 1.67 , 2.0 , 2.33 , 2.67 , 3.0 , 3.33 , 3.67 , 4.0 , 4.5 , 5.0 , 5.5 , 6.0 , 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose.

  From time 0 (administration) to 24 hours post-administration.

• bioavailability

  The ratio of geometric least square means between the T25 and MYCAPSSA® for AUC from time zero to infinity (AUC0-inf) via dose normalization. AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)

  From 0 (administration) to 24hour

• bioavailability

  The ratio of geometric least square means between the T25 under fed condition and under fasted condition for Cmax

  From time 0 (administration) to 24 hours post-administration

• bioavailability

  The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC0-tlast (sampling occurs at the following timepoints: Fasted condition: 0 (pre-dose) , 0.5 , 1.0, 1.33, 1.67, 2.0, 2.33, 2.67, 3.0, 3.33, 3.67, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 9.0, 10.0, 12.0,14.0, 16.0, 24.0 hour post-dose; Fed condition: 0 (pre-dose), 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5 , 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 , 11.0, 12.0, 14.0, 16.0, 24.0 hour post-dose;)

  From time 0 (administration) to 24 hours post-administration.

• bioavailability

  The ratio of geometric least square means between the T25 under fed condition and under fasted condition for AUC from time zero to infinity (AUC0-inf).AUC (0-inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0-t) plus AUC (t-inf)

  From time 0 (administration) to 24hour.

Secondary Outcomes (16)

• PK profile (Tlag)

  From time 0 (administration) to 24 hours post-administration

• PK profile(Tmax)

  From time 0 (administration) to 24 hours post-administration

• PK profile(t₁/₂)

  From time 0 (administration) to 24 hours post-administration

• PK profile(Kel)

  From time 0 (administration) to 24 hours post-administration

• PK profile(CL/F)

  From time 0 (administration) to 24 hours post-administration

Study Arms (3)

T25-Fast

EXPERIMENTAL

T25 administrated in fast state

Drug: T25-Fast

T25 -Fed

EXPERIMENTAL

T25 administrated in fed state

Drug: T25-Fed

mycapssa

ACTIVE COMPARATOR

Mycapssa administrated in fast state

Drug: Mycapssa

Interventions

T25-Fast DRUG

Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state

T25-Fast

Mycapssa DRUG

Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state

mycapssa

T25-Fed DRUG

Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state

T25 -Fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Triastek (Shanghai) Limited: lead
• Zibo Central Hospital: collaborator

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 23, 2026
• Study Start: June 26, 2026
• Primary Completion: July 10, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share