Open-label, Crossover, Food Effect Study to Evaluate CT-044 in Healthy Human Volunteers
NCT04252833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2020-06-12
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.
Conditions
- Pain, Acute
- Acute Pain
- Surgery
- Neuropathy
Interventions
- DRUG
-
CT-044
CT-044 HCl is a reactive species decomposition accelerant
Sponsors & Collaborators
-
CerSci Therapeutics
collaborator UNKNOWN -
Lotus Clinical Research, LLC
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-02-18
- Primary Completion
- 2020-03-16
- Completion
- 2020-03-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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