A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade
Clear Scientific, Inc.
Summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Major Inclusion Criteria: 1. Healthy participants aged 18 to 55 years, inclusive; 2. Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure; 3. A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg; 4. Females must not be lactating and must have a negative pregnancy test during screening and admission. Major Exclusion Criteria: 1. Estimated glomerular filtration rate \<60 mL/min/1.73 m2; 2. History of cardiovascular disease; 3. History of any clinically important disease or…
Interventions
- DrugNaloxone Hydrochloride
Naloxone for intravenous administration
- DrugFentanyl
Fentanyl for intravenous administration
- DrugSterile Saline
Sterile Saline for intravenous administration
- DrugCS-1103
CS-1103 for intravenous administration
Location
- California Clinical Trials Medical GroupGlendale, California