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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.
This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each volunteer will participate in the study for about 20 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBP-711 for SAD | Experimental | A single dose of BBP-711 will be administered orally. |
|
| Placebo for SAD | Placebo Comparator | A single dose of matching placebo will be administered orally. |
|
| BBP-711 for MAD | Experimental | A dose of BBP-711 will be administered orally for multiple days. |
|
| Placebo for MAD | Placebo Comparator | A dose of matching placebo will be administered orally for multiple days. |
|
| BBP-711 for SAD Food Effect | Experimental | A single dose of BBP-711 will be administered orally. |
|
| Placebo for SAD Food Effect | Placebo Comparator | A single dose of matching placebo will be administered orally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBP-711 | Drug | BBP-711, oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence of Adverse Events (AEs) | Baseline to Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessments: Cmax | Maximum observed plasma concentration (Cmax) | Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD |
| Pharmacokinetic Assessments: Cmin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry O'Reilly, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| Placebo | Drug | Placebo matching BBP-711 |
|
Minimum observed plasma concentration (Cmin)
| Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD |
| Pharmacokinetic Assessments: AUC | Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC(0-last)) computed using the linear trapezoidal rule | Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD |
| Pharmacodynamic Assessment: Baseline plasma glycolate | Baseline plasma glycolate | Baseline |
| Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate | Percentage change from baseline plasma glycolate | Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD |
| Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio | Baseline 24 Hour urinary glycolate:creatinine ratio | Baseline |
| Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio | Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio | Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD |