ICON Lenexa
Lenexa, Kansas, 66219, United States
NCT Number: NCT06270511
The aim of this study is to investigate different formulations of S-337395.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Lenexa, Kansas, 66219, United States
This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Administered as an oral suspension.
Administered as an oral suspension.
Time frame: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)
Time frame: Day 1 through Day 21
Time frame: Day 1 through Day 29
Time frame: Venous: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose); Capillary: Days 1, 2, 8, and 9 (Up to 24 hours post dose)
Time frame: Days 1-12 (Predose, up to 96 hours post dose)
Shionogi
Industry
A Phase 1, 2-Part Study to Evaluate the Relative Bioavailability of and Food-Effect on Pharmacokinetics of Different Formulations of S-337395, and to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of S-337395 in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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