Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects

Exposure Clinical Trial

Official title: A First In Human, Single Blind, Placebo Controlled, Randomized Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SP-333 Tablets in Healthy Adult Subjects

Status Completed

Clinical Trial Summary

This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential, escalating, single-dose, study designed to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333 tablets.

Clinical Trial Description

This is a randomized, phase 1, single-blind, placebo controlled, single-dose, study designed to evaluate the safety, tolerability, and pharmacokinetic properties of orally administered SP-333 tablets. The study will include 7 groups of 8 subjects each (6 active, 2 placebo) given a single oral dose of of SP-333 tablets or placebo. Following outpatient screening from approximately 5 to 42 days before dosing, each subject will enter the Clinical Pharmacology Unit (CPU) and will be housed from at least 48 hours, before dosing until 48 hours after dosing. Subjects will be given single dose of the study drug on the day of dosing and remain in the CPU for at least 48 hours. Subjects will return to the CPU on Days 8±1 and 15±1 for safety follow up. Safety Committee Meetings will be conducted to review safety, tolerability, and available Pharmacokinetic data from the current and previous treatment group(s), prior to dosing subsequent treatment groups. Subjects in a given treatment group are considered completers once they have completed the Day 15±1 day Follow up Visit. ;

Related Conditions & MeSH terms

• Exposure

• NCT number: NCT01705938
• Study type: Interventional
• Source: Bausch Health Americas, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: October 2012
• Completion date: December 2012