NCT01705938

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Exposure

Interventions

Type	Name	Description
DRUG	SP-333

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-10-12
• Last updated: 2019-05-24

Locations

1 site across 1 country: United States