Depressive Disorder, Major Clinical Trial
Official title:
A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-911 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
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.
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