At a glance
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Assessing the Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers - An Open Label, Phase I Study
In Brief
A Phase 1 clinical trial evaluating Benfo-oxythiamine for Healthy Volunteers. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The goal of this clinical trial was to learn about the safety and tolerability of an investigational drug called Benfo-oxythiamine (B-OT) in healthy male volunteers. Researchers are studying B-OT to see if it might be used to treat infectious diseases and cancer. This study also looked at how the drug enters, moves through, and leaves the body. The main questions it aimed to answer were: * Is B-OT safe for humans to take? * What medical problems do participants have when taking B-OT? * How much of the drug gets into the blood? Participants: * Took B-OT capsules by mouth either once (single dose group) or once a day for 7 days (multiple dose group). * Stayed in the clinic for several days (4 to 8 nights) for close monitoring. * Gave blood and urine samples for laboratory tests; * Had physical exams, heart rhythm checks (ECG), and vital sign checks (blood pressure, heart rate, breathing rate, and temperature).
Study Details
Timeline
Interventions
Benfo-oxythiamine (B-OT) is an orally bioavailable prodrug of the thiamine antagonist oxythiamine, formulated as hard gelatin capsules (0.5 mg or 3 mg strengths) containing powder-in-capsule. Upon ingestion, it releases oxythiamine to inhibit transketolase enzymes. In the Single Ascending Dose (SAD) part, B-OT is administered as a single oral dose on Day 1. Dose levels are 0.5 mg, 1 mg, 2 mg, 3 mg, and 5 mg. In the Multiple Ascending Dose (MAD) part, B-OT is administered orally once daily for 7 consecutive days. Dose levels are 1 mg, 2 mg, 3 mg, and 5 mg. Administration occurs after an overnight fast of at least 10 hours with 240 mL of water.