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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01DA058548-02 | 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, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants receive methamphetamine HCl (30 mg) followed by placebo (saline). |
|
| Active | Active Comparator | Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methamphetamine | Drug | Methamphetamine HCl 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 and magnitude of urine excretion of methamphetamine | Measurement of concentration of methamphetamine in urine | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time course of CS-1103 blood and urine concentrations | Measurement of plasma and urine concentrations of CS-1103 | 48 hours |
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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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| Sterile Saline |
| Drug |
Sterile Saline for intravenous administration |
|
| CS-1103 | Drug | CS-1103 for intravenous administration |
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| ID | Term |
|---|---|
| D008694 | Methamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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