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This trial is a Phase I, single-center, randomized, double-blind, placebo-controlled study conducted in healthy Chinese adult subjects.
The purpose of this study is to learn about:
This study is divided into two parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of PRT-064040 nasal spray | Experimental |
| |
| Single dose of Placebo | Placebo Comparator |
| |
| Multiple doses of PRT-064040 nasal spray | Experimental |
| |
| Multiple doses of Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRT-064040 nasal spray | Drug | A single dose of PRT-064040 nasal spray at one of six dose levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | From first dose to maximum of 2 days post last dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters: Cmax | Up to 2 days post last dose administration | |
| Pharmacokinetic Parameters: Tmax | Up to 2 days post last dose administration | |
| Pharmacokinetic Parameters: AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Changsha | Changsha | Hunan | China |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo | Drug | A single dose of Placebo at one of six dose levels |
|
| PRT-064040 nasal spray | Drug | Multiple doses of PRT-064040 nasal spray at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days |
|
| Placebo | Drug | Multiple doses of Placebo at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days |
|
| Up to 2 days post last dose administration |
| Pharmacokinetic Parameters: Half life | Up to 2 days post last dose administration |
| D009422 | Nervous System Diseases |