A Research Study to Evaluate BLX-7006 in 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-7006, which acts like the hormone Glucagon-like Peptide-1 (GLP-1) to help control blood sugar and body weight. Current GLP-1 medicines are given by injection. This study will see if BLX-7006 is safe, how the body processes it, and whether food changes how it is absorbed. The main goal is to see if BLX-7006 is safe and well tolerated. Secondary objectives of the study will measure how BLX-7006 moves through the body after an oral dose, including how quickly it is absorbed, how long it stays in the blood, and how the body removes it. It will also look at how the drug affects the body by looking at markers of glucose metabolism.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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-7006
DrugBLX-7006 Single or Multiple doses administered orally as a tablet
Placebo
DrugParticipants will receive matching placebo of BLX-7006 for each of the oral cohorts.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: BLX-7006 Oral DoseExperimental treatment 1 intervention
Group B: Placebo to match BLX-7006Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who experienced Adverse Events (AEs)
The safety and tolerability of oral BLX-7006 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-7006 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-7006 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-7006 in single, food effect, and multiple ascending doses in healthy adults
Time frame
Up to 14 days after last dose in each cohort2
Assess time to maximum concentration (Tmax)
Evaluate the relative bioavailability of BLX-7006 in single, food effect, and multiple ascending doses in healthy adults
Time frame
Up to 14 days after last dose in each cohort3
Assess the area under the concentration-time curve from time 0 to infinity (AUCinf)
Evaluate the relative bioavailability of BLX-7006 in single, food effect, and multiple ascending doses in healthy adults
Time frame
Up to 14 days after last dose in each cohort4
Assess the area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)
Evaluate the relative bioavailability of BLX-7006 in single, food effect, and multiple ascending doses in healthy adults
Time frame
Up to 14 days after last dose in each cohortSponsors and contacts
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Source ClinicalTrials.gov
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