AcromegalyPhase 1NCT07663318
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)
A Phase 1 study testing T25-Fast, Mycapssa and T25-Fed in people with Acromegaly, run by Triastek (Shanghai) Limited at 1 site in China.
Trial 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. How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa？ 2. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- What is being tested?
- T25-Fast, Mycapssa and T25-Fed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2026to 24 Jul 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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：
- How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa？
- 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.
- Conditions
- Acromegaly
- Being tested
- T25-Fast, Mycapssa, T25-Fed
- Keywords
- Octreotide
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T25-FastDrug
Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fast state
MycapssaDrug
Participants received a single dose ( 20 mg, 1 granule on days 1, 4, and 10 under fast state
T25-FedDrug
Participants received a single dose ( 8 mg, 1 tablet) on days 1, 4, and 10 unde fed state
| Study group | Role | What they receive |
|---|---|---|
| T25-Fast | Experimental | T25 administrated in fast state Receives: Drug: T25-Fast |
| T25 -Fed | Experimental | T25 administrated in fed state Receives: Drug: T25-Fed |
| mycapssa | Active comparator | Mycapssa administrated in fast state Receives: Drug: Mycapssa |
What is being measured
The primary outcome is the main question the study is designed to answer.
bioavailability
The ratio of geometric least square means between the T25 and MYCAPSSA® for maximum observed drug concentration (Cmax)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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;)
Measured: 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)
Measured: From time 0 (administration) to 24hour.
Secondary outcomes (16)
PK profile (Tlag)
the first observation with a measurable (non-zero) concentration (Tlag)
Measured: From time 0 (administration) to 24 hours post-administration
PK profile(Tmax)
time to reach maximum plasma concentration
Measured: From time 0 (administration) to 24 hours post-administration
PK profile(t₁/₂)
elimination half-life (t₁/₂)
Measured: From time 0 (administration) to 24 hours post-administration
PK profile(Kel)
elimination rate constant
Measured: From time 0 (administration) to 24 hours post-administration
PK profile(CL/F)
apparent total clearance after oral administration
Measured: From time 0 (administration) to 24 hours post-administration
PK profile(Vz/F)
apparent volume of distribution after oral administration
Measured: From time 0 (administration) to 24 hours post-administration
PK profile(AUC_%Extrap)
percentage of area under the concentration-time curve extrapolated beyond the last measurable concentration
Measured: From time 0 (administration) to 24 hours post-administration
the gastrointestinal transit of T25 using an abdominal X-ray
the abdominal X-ray
Measured: 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
the abdominal X-ray
Measured: 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
Incidence and severity of AE
Measured: From the first dose until 7 days after the last dose
Safety and tolerability -Temperature (ear)
Incidence of Adverse Events and Abnormalities as assessed by Temperature (ear)
Measured: From the first dose until 7 days after the last dose
Safety and tolerability - Blood pressure
Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
Measured: From the first dose until 7 days after the last dose
Safety and tolerability -Pulse
Incidence of Adverse Events and Abnormalities as assessed by pulse
Measured: From the first dose until 7 days after the last dose
Safety and tolerability - Physical examination
Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination
Measured: From the first dose until 7 days after the last dose
Safety and tolerability - clinical laboratory tests
Number of abnormalities assessed based on safety bloods and urine test( hematology, blood biochemistry, coagulation function, urinalysis, thyroid function, serum vitamin B12, serum pregnancy test (only for females), etc)
Measured: From the first dose until 7 days after the last dose
Safety and tolerability - ECG
Heart Rate, PR Interval, QRS duration,QT Interval,QTc Interval
Measured: From the first dose until 7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start25 Jun 2026
- Primary completion22 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triastek (Shanghai) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zibo Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663318
- Sponsor's protocol ID
- T25-101
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No