NCT04252833

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Lotus Clinical Research, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pain, Acute
• Acute Pain
• Surgery
• Neuropathy

Interventions

Type	Name	Description
DRUG	CT-044	CT-044 HCl is a reactive species decomposition accelerant

Timeline

• Start date: 2020-02-18
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2020-02-05
• Last updated: 2020-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study