This a phase 1, partially blinded, randomized, crossover study to determine the pharmacokinetics (PK) and QT/QTc interval of study drug (ESK-001) in healthy volunteer participants,
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
Fortrea CRU
Daytona Beach, Florida, United States
Change from baseline in placebo-adjusted QTcF (∆∆QTcF)
Time frame: 24 hours
Change from baseline in ECG parameter ΔHR
Time frame: 24 hours
Change from baseline in ECG parameter Δ PR interval
Time frame: 24 hours
Change from baseline in ECG parameter ΔQRS duration
Time frame: 24 hours
Change from baseline in ECG parameter ΔQTc interval
Time frame: 24 hours
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time frame: Up to 22 Days
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Time frame: Up to 22 Days
Composite of pharmacokinetic (PK) parameter Vz/F for ESK-001 and metabolites
Time frame: 24 hours
Composite of pharmacokinetic (PK) parameter Cmax for ESK-001 and metabolites
Time frame: 24 hours
Composite of pharmacokinetic (PK) parameter tmax for ESK-001 and metabolites
Time frame: 24 hours
Composite of pharmacokinetic (PK) parameter CL/F for ESK-001 and metabolites
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Time frame: 24 hours