A Randomized, Double-Blinded, Placebo-Controlled QTc Study to Evaluate BIA 28-6156 Effect on Cardiac Repolarization in Healthy Volunteers
Abstract
Mutations in the GBA1 gene, encoding beta-glucocerebrosidase (GCase), are the most common genetic risk factor for Parkinson's Disease (PD). BIA 28-6156, an allosteric activator of GCase, is under development for the treatment of GBA-associated PD. This Phase 1, randomized, double-blind, placebo-controlled, crossover study assessed the impact of BIA 28-6156 on QT interval corrected (QTc) for heart rate (HR) based on the Fridericia correction (QTcF) in 37 healthy subjects. Participants received single doses of 60 or 150 mg BIA 28-6156, 400 mg moxifloxacin, or placebo in a cross-over design. The relationship between BIA 28-6156 plasma levels and QTcF changes (ΔQTcF) was analyzed to exclude a ΔΔQTcF > 10 ms. Heart rate, PR, and QRS intervals, electrocardiogram (ECG) waveform morphology, and adverse events (AEs) were also evaluated. The concentration-QTc analysis indicated no effect on ΔΔQTcF exceeding 10 ms up to BIA 28-6156 plasma levels of ≈7150 ng/mL. No clinically significant effects on ECG parameters were observed, and BIA 28-6156 was generally well tolerated, with no deaths or serious AEs. This study concluded that BIA 28-6156 has no clinically relevant impact on ECG parameters, confirming a negative thorough QT/QTc study.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 37 participants or records.
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