AK3280 / Ark Biosci 
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 0 Diseases   1 Trial   1 Trial   10 News 
  • ||||||||||  AK3280 / Ark Biosci
    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.
  • ||||||||||  AK3280 / Ark Biosci
    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
  • ||||||||||  AK3280 / Ark Biosci
    Enrollment open:  A Study of AK3280 in Chinese Healthy Volunteers (clinicaltrials.gov) -  Jun 28, 2021   
    P1,  N=36, Recruiting, 
    Recruiting --> Completed | N=36 --> 24 Not yet recruiting --> Recruiting
  • ||||||||||  AK3280 / Ark Biosci
    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
  • ||||||||||  AK3280 / Ark Biosci
    Enrollment open:  A Study to Assess the Effect of AK3280 on Renal Function in Healthy Subjects (clinicaltrials.gov) -  Oct 2, 2019   
    P1,  N=36, Recruiting, 
    Recruiting --> Completed | N=36 --> 48 | Trial completion date: Dec 2019 --> Sep 2020 | Trial primary completion date: Dec 2019 --> Sep 2020 Not yet recruiting --> Recruiting