The goal of this study is to explore the safety, drug concentrations and effects on adrenal gland hormones after a single dose or multiple doses of OMS1620 in healthy participants. In addition, the effect of food on drug concentrations will also be tested.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
84
Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Day 1 to approximately day 25
Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma
Time frame: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration
Food Effect (FE) on Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma
Time frame: Two separate assessments (one fasted, one after a high fat meal) of 7 days duration
Safety and tolerability as measured by incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: enrollment to approximately Day 25
Pharmacokinetics (PK) of OMS1620 as assessed by maximum concentration (Cmax) in plasma
Time frame: Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)
Pharmacokinetics (PK) of OMS1620 as assessed by area under the plasma concentration versus time curve (AUC) in plasma
Time frame: Day 1 to Day 7 (SAD) or Day 1 to Day 11 (MAD)
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