Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02209987 | Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults | PHASE1 | COMPLETED | 28 | — | — | Aug 1, 2014 | Oct 1, 2014 | Oct 27, 2014 | 1 | New Zealand |
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable: * Cmax: maximum observed concentration of drug in plasma * AUClast: concentration of drug from time zero to the last quantifiable concentration * AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
| Arm | Type | Description |
|---|---|---|
| GS-5745 SC | EXPERIMENTAL | Participants will receive a single dose of GS-5745 by SC injection. |
| GS-5745 IV | EXPERIMENTAL | Participants will receive a single dose of GS-5745 by IV infusion. |
| Name | Type | Description |
|---|---|---|
| GS-5745 SC | DRUG | GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe |
| GS-5745 IV | DRUG | GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials |
Inclusion Criteria: * In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination * Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods * Screening laboratory evaluations m...