A phase 1 open-label study evaluating the effects of food on TAS-205 in healthy volunteers

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Orally administer 1600mg of TAS‐205 fasting or after meals. After the washout period, orally administer 1600mg of TAS‐205 again by crossover CONDITION: Duchenne Muscular Dystrophy PRIMARY OUTCOME: Pharmacokinetic parameters [Cmax, AUClast, AUCinf] INCLUSION CRITERIA: (1) Healthy adult male subjects who provided written informed consent to participate in the study (2) Aged 18 years or older and younger than 40 years at the time of informed consent (3) Body weight of 60 kg or more and body mass inde Xof 18.5 or more and less than 25.0 at the time of screening tests (4) Capable of oral intake.
Epistemonikos ID: d2e81a63ac30dbfea57597c0abc9ca38cc2ce10e
First added on: Aug 26, 2024