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

Purpose

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).

Conditions

  • Fentanyl Overdose
  • Fentanyl Poisoning

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 <90 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
  • Drug: Naloxone Hydrochloride
    Naloxone for intravenous administration
  • Drug: Fentanyl
    Fentanyl for intravenous administration
  • Drug: Sterile Saline
    Sterile Saline for intravenous administration
Active Comparator
Active 		Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
  • Drug: Naloxone Hydrochloride
    Naloxone for intravenous administration
  • Drug: Fentanyl
    Fentanyl for intravenous administration
  • Drug: CS-1103
    CS-1103 for intravenous administration

Recruiting Locations

California Clinical Trials Medical Group
Glendale, California 91206
Contact:
Lev Gertsik, M.D.
888-228-7425
study.losangeles@parexel.com

More Details

Status
Recruiting
Sponsor
Clear Scientific, Inc.

Study Contact

Anna Del Rosario, B.S.
617-621-8500
adelrosario@clearsci.com