A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorClear Scientific, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Estimated glomerular filtration rate <90 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.
Trial design
Treatments tested in this trial
- Naloxone Hydrochloride
- Fentanyl
- Sterile Saline
- CS-1103
Treatment groups
16 Participants
are divided into 2 treatment groupsSponsors and collaborators
Clear Scientific, Inc.
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov