A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
NCT04154501 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2019-11-06
Summary
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Conditions
- Chronic Pain
- Nociceptive Pain
- Pain
Interventions
- DRUG
-
CNTX-6016
Oral Dose CNTX-6016
- OTHER
-
Other: Placebo
Oral Dose Placebo
Sponsors & Collaborators
-
Centrexion Therapeutics
lead INDUSTRY
Principal Investigators
-
Randall M Stevens, MD · Centrexion Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-04
- Primary Completion
- 2019-08-21
- Completion
- 2019-08-26
- FDA Drug
- Yes
Countries
- United States
Study Locations
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