Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 2-part study. Parts 1 and 2 will be a randomized, double-blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) of orally administered INV-101 in healthy adult subjects. Food effect will also be assessed in one cohort in Part 1.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD A | Experimental |
| |
| SAD B | Experimental |
| |
| SAD C | Experimental |
| |
| MAD A | Experimental |
| |
| MAD B | Experimental |
| |
| MAD C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INV-101 | Drug | SAD MAD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Analysis | Adverse Events: AEs will be coded using the most current version of Medical Dictionary for Regulatory Activities® (MedDRA®). A by-subject AE data listing, including verbatim term, preferred term, treatment (INV-101 or placebo), severity, and relationship to drug, will be provided. The number of subjects experiencing treatment-emergent adverse events (TEAEs) and the number of TEAEs will be summarized by study part and treatment (INV-101 or placebo) using frequency counts. | 7 days after last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | AUC0-12, AUC0-t, AUC0-inf | 3 days |
| Peak Plasma Concentration (Cmax) | 3 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron | Baltimore | Maryland | 02451 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
8 subjects were randomized to 6 Active and 2 Placebo in each cohort.
Not provided
Not provided
Not provided
| INV-101 Placebo | Drug | SAD MAD |
|