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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This is an open-label, two period, fixed-sequence, drug-drug interaction study to compare the PK and PD of orally administered AV-101 alone and in combination with probenecid in healthy subjects. In Treatment Period 1, subjects will receive AV-101 following an overnight fast of at least 8 hours. In Treatment Period 2, subjects will fast overnight for at least 8 hours, and then receive AV-101 2 hours after receiving 1,000 mg probenecid. Each Treatment Period will be separated by a washout period. The doses of AV-101 in Cohort 1 and a possible Cohort 2 will be 360 mg and 720 mg, respectively. Optional Cohorts 3 and 4 may be enrolled depending on results from Cohorts 1 and 2. CSF will be collected via indwelling catheter to determine the PK of AV-101 and its active metabolite 7-Cl-KYNA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AV-101 | Experimental | AV-101 360 mg oral capsules single dose |
|
| AV-101 + Probenecid | Experimental | AV-101 360 mg oral capsules + 1000 mg Probenecid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV-101 | Drug | 360 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and CSF concentrations of 7-chloro-kynurenic acid (7-Cl-KYNA) in ng/ml | Difference in 7-Cl-KYNA levels after AV-101 with and without probenecid | 24 hours |
| Plasma and CSF concentrations of 4-chloro-kynurenine (AV-101) in ng/ml | Difference in 4-Cl-KYN levels after AV-101 with and without probenecid | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Parexel Phase 1 Unit | Contact | 888-228-7495 | study.losangeles@parexel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Clinical Unit | Recruiting | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| C027883 | 4-chlorokynurenine |
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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AV-101 alone followed by AV-101 + Probenecid
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| Probenecid | Drug | 1000 mg oral |
|
| Sulfur Compounds |