Open-label, Crossover, Food Effect Study to Evaluate CT-044 in Healthy Human Volunteers

Surgery Clinical Trial

Official title: Open-label, Crossover, Food Effect Study to Evaluate the Single Dose Pharmacokinetics of CT-044, a Reactive Species Decomposition Accelerant, in Healthy Human Volunteers

Status Completed

Clinical Trial Summary

This open-label study will be conducted to assess the bioavailability and PK of oral single doses of CT-044 following administration with and without food and to evaluate the safety and tolerability of CT-044 when given with and without food.

Clinical Trial Description

The food effect study will be an open-label, 2-sequence, balanced crossover design in 12 subjects previously untreated with CT-044.

Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing and remain in house until Day 3. Each subject will receive CT-044 single oral dose once under fed conditions (i.e., a high fat meal per FDA recommendations) and once in the fasted state.

9 Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up. Subjects will return to the Clinical Trial Unit to be treated by the second sequence after a washout period of at least 7 days, but no more than 14 days. All procedures will be repeated for the second treatment sequence. When possible, the procedures conducted at the 144-hour follow-up visit for the first sequence may serve as baseline for the second sequence of the crossover. ;

Related Conditions & MeSH terms

• Acute Pain
• Neuropathy
• Pain, Acute
• Surgery

• NCT number: NCT04252833
• Study type: Interventional
• Source: Lotus Clinical Research, LLC
• Status: Completed
• Phase: Phase 1
• Start date: February 18, 2020
• Completion date: March 16, 2020