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New octreotide pill faces off against current capsule in healthy volunteer study

NCT ID NCT07663318

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 7 times

Summary

This early-stage trial in 18 healthy adults compares a new octreotide tablet (T25) with an existing capsule (MYCAPSSA) to see how much drug gets into the blood. It also checks whether a high-fat meal changes absorption of the tablet. Participants take single doses under fasting or fed conditions, and blood samples are collected over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
octreotide acetate
What this could lead to
If successful, this could help develop a more convenient oral form of octreotide for people with acromegaly.
What could go wrong
This is a very early Phase 1 study in only 18 healthy people, so results may not apply to patients or predict long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Jun 2026

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male or female aged 18 to 55 years (both inclusive). 2. 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. 3. 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 4. 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). 5. Participants must fully understand and voluntarily sign the informed consent form prior to the initiation of any study procedures. 6. Participants with high compliance for all protocol requirements. Exclusion Criteria: 1. Participants with allergic disease or allergic to investigational products or its excipients, or more than two kinds of medications, food, or beverage. 2. Participants with positive for human immunodeficiency virus (HIV) antibody test; active infection with Hepatitis B, C; positive treponema pallidum antibody test. 3. 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. 4. 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. 5. AST \> ULN or bilirubin \> ULN. 6. Creatinine clearance \<90 mL/min during screening (calculation formula of Creatinine Clearance is detailed in Section 8.2.1.6). 7. Participants with a history or presence of hypothyroidism. 8. 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. 9. 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). 10. 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. 11. Participants who have donated or lost blood \> 400 mL within 3 months before the initial administration. 12. Participants who have received major surgery or hospitalized within 3 months before the initial administration. 13. Participants who have received investigational drugs or participated in other clinical trials within 3 months before the initial administration. 14. Participants who have received prescription drug within 14 days before the initial administration. 15. Participants who have taken high-density medications such as bismuth agents and calcium agents within 7 days before the initial administration. 16. Participants who have received over the counter (OTC) drug or herb within 7 days before the initial administration. 17. Participants who have consumed grapefruit juice, or other food or beverage containing caffeine or xanthine within 7 days before the initial administration. 18. Participants who have drunk alcohol within 48 hours before the initial administration or with a positive breath alcohol test (\> 0 mg/100 mL). 19. Participants cannot receive standard meals during the study. 20. Participants who cannot tolerate venipuncture or have a history of fear of needles or hemophobia. 21. Participants with vitamin B12 deficiency. 22. Participants with acute minor diseases (common cold, diarrhea, etc.) during screening. 23. 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. 24. Participants who are not suitable for participating in this study due to other reasons as judged by Investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Zibo Central Hospital

    Zibo, Shandong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.