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A Research Study to Evaluate BLX-0871 in Healthy Adults

ConditionNormal Healthy Adults
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiolexis Therapeutics

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

History of diabetes, clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurologic disease, or abnormal labs/Echocardiograms (ECG) deemed clinically relevant.

Prior gastrointestinal (GI) surgery affecting absorption (e.g., gastric bypass) or chronic GI disorders.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BLX-0871

    Drug

    BLX-0871 Single or Multiple doses administered orally as a tablet

  • Placebo

    Drug

    Participants will receive matching placebo of BLX-0871 for each of the oral cohorts.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: BLX-0871 Oral DoseExperimental treatment 1 intervention
Group B: Placebo to match BLX-0871Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who experienced Adverse Events (AEs)

The safety and tolerability of oral BLX-0871 administration will be evaluated based on the incidence of adverse effects in subjects, as assessed according to CTCAE v5.0. The number of participants who experience an AE will be reported.

Time frame
From first dose through End of Study (up to ~28 days per participant)
2

Number of participants who experienced Serious Adverse Events (SAEs)

The safety and tolerability of oral BLX-0871 administration will be evaluated based on the incidence of SAE in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a SAE will be reported.

Time frame
From first dose through End of Study (up to ~28 days per participant)
3

Number of participants who experienced Treatment-Related Adverse Avents (TRAEs)

The safety and tolerability of oral BLX-0871 administration will be evaluated based on the incidence of TRAEs in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a TRAE will be reported.

Time frame
From first dose through End of Study (up to ~28 days per participant)

Secondary outcomes

1

Assess maximum observed drug concentration (Cmax)

Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults

Time frame
Up to 14 days after last dose in each cohort
2

Assess time to maximum concentration (Tmax)

Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults

Time frame
Up to 14 days after last dose in each cohort
3

Assess the area under the concentration-time curve from time 0 to infinity (AUCinf)

Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults

Time frame
Up to 14 days after last dose in each cohort
4

Assess the area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)

Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults

Time frame
Up to 14 days after last dose in each cohort

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Nucleus Network St Kilda Road Status unavailable Melbourne, New South WalesAustraliaAustralia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biolexis Therapeutics

Lead sponsor

Source ClinicalTrials.gov

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