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| ID | Type | Description | Link |
|---|---|---|---|
| 5UG3DA059286 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline). |
|
| Active | Active Comparator | Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone Hydrochloride | Drug | Naloxone for intravenous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations | Physical examinations | 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 | 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 | 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 | 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 | 48 hours |
| Time course and magnitude of urine excretion of fentanyl | Measurement of concentration of fentanyl in urine | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours |
| Effect of CS-1103 on the naloxone plasma and urine PK, if any |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Del Rosario, B.S. | Contact | 617-621-8500 | adelrosario@clearsci.com | |
| Piercen Oliver, Ph.D. | Contact | 617-621-8500 | poliver@clearsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinhua Li, Ph.D. | Clear Scientific, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Recruiting | Glendale | California | 91206 | United States |
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| Fentanyl |
| Drug |
Fentanyl for intravenous administration |
|
| Sterile Saline | Drug | Sterile Saline for intravenous administration |
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| CS-1103 | Drug | CS-1103 for intravenous administration |
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Measurement of standard urine and plasma PK parameters between placebo and CS-1103 treated participants
| 48 hours |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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