A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade

Phase 2Not Yet RecruitingNCT07459166

Clear Scientific, Inc.16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fentanyl Overdose Fentanyl Poisoning

Interventions

Naloxone HydrochlorideDRUG

Naloxone for intravenous administration

FentanylDRUG

Fentanyl for intravenous administration

Sterile SalineDRUG

Sterile Saline for intravenous administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 disorder which, in the opinion of the Investigator, may interfere with safe study participation.

Locations (1)

California Clinical Trials Medical Group

Glendale, California, United States

Outcomes

Primary Outcomes

Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations

Physical examinations

Time frame: 3 days plus follow-up on Day 10

Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)

Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted

Time frame: 3 days plus follow-up on Day 10

Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs

Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature

Time frame: 3 days plus follow-up on Day 10

Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters

Clinical chemistry, hematology, coagulation, and urinalysis

Time frame: 3 days plus follow-up on Day 10

Time course of CS-1103 blood and urine concentrations

Measurement of plasma and urine concentrations of CS-1103

Time frame: 48 hours

Time course and magnitude of urine excretion of fentanyl

Measurement of concentration of fentanyl in urine

Time frame: 48 hours

Secondary Outcomes

Effect of CS-1103 and fentanyl on QT interval

Concentration-QT correlation performed on baseline-corrected QTcF time-matched with PK for fentanyl and CS-1103 in plasma

Time frame: 48 hours

Central Contacts

Anna Del Rosario, B.S.

CONTACT

617-621-8500 adelrosario@clearsci.com

Piercen Oliver, Ph.D.

CONTACT

617-621-8500 poliver@clearsci.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.