Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT03155503
Brief Summary:
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.
Detailed Description:
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:
NCT03155503
Study Brief:
Protocol Section:
NCT03155503