This is a Phase 1, conventional, double-blind, placebo-controlled, single-center clinical study comprised of 2 segments (Segment 1 and Segment 2) in which single and multiple doses of SUVN-911 or placebo will be orally administered to healthy male subjects to evaluate the safety, tolerability, and pharmacokinetic profile.
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-911 administered orally once a day to healthy male subjects. The study will be conducted under double-blind conditions. The primary objectives are to evaluate the safety and tolerability of SUVN-911 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-911, if possible. The secondary objectives are to evaluate the single and repeat dose plasma and urine pharmacokinetics of SUVN-911 following oral administration of single and multiple ascending doses in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
QuintilesIMS Phase 1 Services, LLC
Kansas City, Kansas, United States
ECG (Electrocardiogram)
electrocardiogram outcomes
Time frame: Range of Day 1-17
Vital signs
blood pressure determination
Time frame: Range of Day 1-17
C-SSRS (Columbia Suicidal Severity Rating Scale)
Columbia Suicidal Severity Rating in multiple doses
Time frame: Range of Day 1-17
Area under the plasma concentration versus time curve (AUC)
Plasma concentration
Time frame: Day 1 and Day 14
Maximum observed concentration (Cmax)
Maximum concentration observed
Time frame: Day 1 and Day 14
Time to reach maximum concentration (Tmax)
Determination of maximum time taken to reach the maximum concentration
Time frame: Day 1 and Day 14
Terminal half-life (t½)
Elimination rate
Time frame: Day 1 and Day 14
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