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
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Clear Scientific, Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Major Inclusion Criteria:
- •Healthy participants aged 18 to 55 years, inclusive;
- •Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;
- •A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;
- •Females must not be lactating and must have a negative pregnancy test during screening and admission.
Exclusion Criteria
- •Estimated glomerular filtration rate \<60 mL/min/1.73 m2;
- •History of cardiovascular disease;
- •History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Arms & Interventions
Active
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
Intervention: CS-1103 (Drug)
Placebo
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
Intervention: Naloxone Hydrochloride (Drug)
Placebo
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
Intervention: Fentanyl (Drug)
Placebo
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
Intervention: Sterile Saline (Drug)
Active
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
Intervention: Naloxone Hydrochloride (Drug)
Active
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
Intervention: Fentanyl (Drug)
Outcomes
Primary Outcomes
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Time Frame: 3 days plus follow-up on Day 10
Physical examinations
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Time Frame: 3 days plus follow-up on Day 10
Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
Time Frame: 3 days plus follow-up on Day 10
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
Time Frame: 3 days plus follow-up on Day 10
Clinical chemistry, hematology, coagulation, and urinalysis
Time course of CS-1103 blood and urine concentrations
Time Frame: 48 hours
Measurement of plasma and urine concentrations of CS-1103
Time course and magnitude of urine excretion of fentanyl
Time Frame: 48 hours
Measurement of concentration of fentanyl in urine
Secondary Outcomes
- Effect of CS-1103 and fentanyl on QT interval(48 hours)
- Effect of CS-1103 on the naloxone plasma and urine PK, if any(48 hours)