Trial reportClinical pharmacology in drug development2026
A Randomized, Double-Blinded, Placebo-Controlled QTc Study to Evaluate BIA 28-6156 Effect on Cardiac Repolarization in Healthy Volunteers.
Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
6 authors.
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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.
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