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This is a two-part randomized, double-blind, placebo-controlled study.
This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL |
|
| Placebo | Placebo Comparator | Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP-3D (diethylamide) | Drug | SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Reported AEs | The time of providing written informed consent until 30 days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters 1 | Lag time (Tlag) | 6 days |
| PK parameters 2 | Time to reach maximum (peak) plasma concentration following drug administration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Contact | 8007693518 | info@southrampartpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Hernan A Bazan, MD | CEO | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences-Miami, Inc. | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Double-blind
| Placebo | Drug | Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL |
|
|
| 6 days |
| PK parameters 3 | Maximum (peak) plasma drug concentration (Cmax) | 6 days |
| PK parameters 4 | Area under the plasma concentration-time curve from time zero to infinity (AUCinf) | 6 days |
| PK parameters 5 | Area under the plasma concentration-time curve from time zero to infinity (AUClast) | 6 days |
| PK parameters 6 | Area under the plasma concentration-time curve (AUC0-tau) | 6 days |
| PK parameters 7 | Terminal disposition rate constant/terminal rate constant (λz) | 6 days |
| PK parameters 8 | Elimination half-life (T1/2) | 6 days |
| PK parameters 9 | Apparent total clearance of the drug from plasma after oral administration (CL/F) | 6 days |
| PK parameters 10 | Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F) | 6 days |