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Journal: Comparative Evaluation of Particle Size Reduction, Salt Formation, and Amorphous Formulation on the Biopharmaceutical Performance of a Weak Base Drug Candidate. (Pubmed Central) - Oct 4, 2023 In this work, guided by an in silico solubility sensitivity analysis for oral absorption, a comparative assessment of the biopharmaceutical performance of a jet-milled free base, a tosylate salt, and a 50:50 (w/w) amorphous solid dispersion (ASD) with hydroxypropyl methylcellulose acetate succinate (HPMCAS) of a weak base drug candidate, GDC-3280, was conducted...Finally, a pharmacokinetic study in dogs showed that the in vivo exposure increased by 1.7- to 2-fold for the tosylate salt and ASD formulation compared with the jet-milled free base, consistent with the in silico solubility sensitivity analysis for the fraction of drug absorbed. Overall, this work provides insights into the evaluation of multiple formulation approaches for enhancing the biopharmaceutical performance of poorly water-soluble drugs.
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Trial completion, Enrollment change: A Study of AK3280 in Chinese Healthy Volunteers (clinicaltrials.gov) - Apr 7, 2022 P1, N=24, Completed, Overall, this work provides insights into the evaluation of multiple formulation approaches for enhancing the biopharmaceutical performance of poorly water-soluble drugs. Recruiting --> Completed | N=36 --> 24
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Clinical, P1 data, PK/PD data, Journal: A phase 1, randomized study to evaluate safety, tolerability, and pharmacokinetics of GDC-3280, a potential novel anti-fibrotic small molecule, in healthy subjects. (Pubmed Central) - Jun 25, 2021 Not yet recruiting --> Recruiting Single and multiple doses of GDC-3280 were generally well tolerated, with acceptable safety and pharmacokinetic profiles that support twice-daily, oral administration with food in future clinical trials.
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Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects (clinicaltrials.gov) - Jun 9, 2021 P1, N=48, Completed, Single and multiple doses of GDC-3280 were generally well tolerated, with acceptable safety and pharmacokinetic profiles that support twice-daily, oral administration with food in future clinical trials. Recruiting --> Completed | N=36 --> 48 | Trial completion date: Dec 2019 --> Sep 2020 | Trial primary completion date: Dec 2019 --> Sep 2020
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