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

ConditionsFentanyl OverdoseFentanyl Poisoning
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Naloxone Hydrochloride

    Drug

    Naloxone for intravenous administration

  • Fentanyl

    Drug

    Fentanyl for intravenous administration

  • Sterile Saline

    Drug

    Sterile Saline for intravenous administration

  • CS-1103

    Drug

    CS-1103 for intravenous administration

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 3 interventions
Group B: ActiveActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

Effect of CS-1103 on the naloxone plasma and urine PK, if any

Measurement of standard urine and plasma PK parameters between placebo and CS-1103 treated participants

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clear Scientific, Inc.

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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