Healthy volunteers test new diabetes drug formulation
NCT ID NCT07056517
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study looked at how healthy adults process a drug called lobeglitazone, given as two different tablet types (a standard tablet and a melt-in-the-mouth tablet). Twenty-one participants took single doses under fasting and fed conditions to measure drug levels and safety. The goal was to gather basic information, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lobeglitazone
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
-
21 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
-
Sep 2025
- 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 Hide 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 and female participants aged 18 to 55 years (inclusive) at the time of informed consent. 2. Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening. 3. Body weight ≥50 kg at Screening. 4. Capable of giving informed consent and complying with study procedures. 5. Female participants must be of non-childbearing potential (postmenopausal or surgically sterile) or, if of childbearing potential, must agree to use acceptable contraception. 6. Participants must be non-smokers and must not have used any nicotine-containing products within 30 days prior to Screening and throughout the study. 7. Normal findings in physical examination, clinical laboratory tests, vital signs, and ECG, or findings considered not clinically significant by the investigator. 8. Willing to abstain from alcohol, grapefruit products, and caffeine as per study restrictions. 9. Willing to refrain from strenuous physical activity as specified in the protocol. 10. Male participants must agree to use contraception and avoid sperm donation during the study and for a specified period after. 11. Female participants of childbearing potential must agree to refrain from egg donation during the study and for at least 30 days after the last dose of study drug. Exclusion Criteria: 1. Pregnant or breastfeeding females, or individuals (male or female) actively trying to conceive. 2. History of drug or alcohol use disorder within the past 2 years. 3. Active smoker or user of nicotine products (\>5 cigarettes/week) or positive cotinine test at admission. 4. Difficulty with venipuncture or history of coagulopathy/endocarditis. 5. Significant history of cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, endocrine, hematologic, or psychiatric disorders. 6. History of malignancy not in complete remission for at least 5 years (except localized basal/squamous cell skin cancer or prostate cancer deemed controlled). 7. Use of any prescription or over-the-counter medication, vitamins, or herbal supplements within 14 days or 5 half-lives prior to screening. 8. Use of any prescription medication, over-the-counter medication, or herbal supplements (other than permitted contraceptives or as approved by the investigator) from Screening until completion of the study. 9. Elevated resting blood pressure (systolic \>140 mmHg or diastolic \>90 mmHg) or heart rate \>100 bpm. 10. History of major surgery within 4 weeks or minor surgery within 2 weeks of dosing. 11. Recent flu-like illness or respiratory infection within 2 weeks, or recent live-virus vaccination within 4 weeks of dosing. 12. Clinically significant ECG abnormalities including QTcF \>450 ms, 2nd/3rd degree atrioventricular block, or incomplete left hemiblock. 13. Known bleeding disorders or history of significant allergic reaction to any drug component used in the study. 14. Blood or plasma donation \>500 mL within 30 days before screening. 15. Any other condition which, in the opinion of the investigator, would preclude safe participation.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nucleus Network Pty Ltd.
Melbourne, Victoria, 3004, Australia
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