Work

Effects of High‐ and Low‐Fat Meals on the Bioavailability and Pharmacokinetics of Votoplam, a HTT Gene Splicing Modifier

Year: 2025

Type: article

Abstract: Votoplam is a novel, orally bioavailable, small molecule HTT gene splicing modifier that is being developed for the treatment of Huntington's disease. This was a single dose, open‐label, two‐period, crossover food effect study that evaluated the effect of high‐ and low‐fat meals on 20 mg votoplam in healthy participants. There was a washout of 21 days between the two periods. Twenty‐six participants completed the study. There were minimal changes in the bioavailability and pharmacokinetics of votoplam following administration of a single dose of 20 mg votoplam when taken with low‐fat and high‐fat meals relative to fasted condition. The mean C max , AUC 0–last , and AUC 0–inf for votoplam following administration of a single dose of 20 mg votoplam were 1.4‐fold, 1.2‐fold, and 1.1‐fold higher, respectively, in high‐fat fed conditions, and were 1.3‐fold, 1.1‐fold, and 1.1‐fold higher, respectively, in the low‐fat fed conditions, when compared to fasted conditions. There were no relevant safety findings in any of the treatment groups. Votoplam can be administered with or without food in patients.

Source: Clinical Pharmacology in Drug Development

DOI: 10.1002/cpdd.1626

Authors: Lucy Lee, Amy‐Lee Richards, Nageswara Reddy, Brian Beers, Lee Golden, Ronald Kong

Institution: PTC Therapeutics (United States)

Language: English

Topic: Genetic Neurodegenerative Diseases

Subfield: Cellular and Molecular Neuroscience

Field: Neuroscience

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $3,800