Tests safety of BLX-0871 pill in healthy adults
Tests whether an oral drug, BLX-0871, is safe in healthy adults.
Plain-language title generated from the registry record
Registry title: A Research Study to Evaluate BLX-0871 in Healthy Adults
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07140081, who can take part
Where in Australia
- Nucleus Network St Kilda RoadMelbourne, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biolexis Therapeutics
- Trial code
- NCT07140081
- Record updated
- 24 August 2025
- Original description
This study will test an oral medicine called BLX-0871, which is being developed to improve metabolic health by activating AMP-activated protein kinase (AMPK), a key regulator of energy balance. The main goal is to see if BLX-0871 is safe and well tolerated when given to healthy adults. The study will also measure how the body processes BLX-0871, including how quickly it is absorbed, how long it stays in the blood, and how it is eliminated. Another objective is to see whether food affects the absorption of BLX-0871. It will also look at how the drug affects the body by looking at markers of AMPK activity.Read full original descriptionShow less
A Phase 1 Randomized, Double-blind, Placebo-controlled Single-ascending Dose and Multiple-ascending Dose (SAD and MAD) Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Isoform-specific AMPK Activator BLX-0871 in Healthy Adults With a Body Mass Index (BMI) of 20 - 35 kg/m2
This study will test an oral medicine called BLX-0871, which is being developed to improve metabolic health by activating AMP-activated protein kinase (AMPK), a key regulator of energy balance. The main goal is to see if BLX-0871 is safe and well tolerated when given to healthy adults. The study will also measure how the body processes BLX-0871, including how quickly it is absorbed, how long it stays in the blood, and how it is eliminated. Another objective is to see whether food affects the absorption of BLX-0871. It will also look at how the drug affects the body by looking at markers of AMPK activity.
Inclusion: Healthy males or females, 18-65 years, BMI 20-35 kilograms/meter² (kg/m²), weight ≥50 kilograms (kg); Normal or clinically acceptable labs, vital signs; HbA1c <6.5%, non-fasting glucose 4.0-7.8 milimol/Liter (mmol/L); Willing to follow contraception requirements, avoid alcohol, nicotine, and blood donation per protocol, and comply with all study visits and procedures.
Exclusion: Prior gastrointestinal (GI) surgery affecting absorption (e.g., gastric bypass) or chronic GI disorders; Use of prescription drugs, Over the counter (OTC) /herbal supplements; Participation in another clinical trial or blood donation within 30 days (or 5 half-lives of prior drug); History of diabetes, clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurologic disease, or abnormal labs/Echocardiograms (ECG) deemed clinically relevant; History or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2); malignancy within 5 years (except treated basal cell or in situ cervical cancer); History of severe allergic reactions, seizures, or psychiatric hospitalization; positive drug, alcohol, or cotinine test; Any condition or history that may compromise safety, study conduct, or compliance, in the opinion of the Investigator.