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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03318809 | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function | PHASE1 | COMPLETED | 12 | — | — | Dec 12, 2017 | Apr 5, 2018 | Jun 23, 2022 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| Group 1: Severely Renal Impaired Participants | EXPERIMENTAL | Participants with severely impaired renal function (estimated glomerular filtration rate \[eGFR\] 15 to 29 mL/min/1.73 m\^2) receive a single oral dose of 200 mg AMG 986. |
| Group 2: Healthy Participants | ACTIVE_COMPARATOR | Participants with normal renal function (eGFR \>= 90 mL/min/1.73 m\^2 or above) receive a single oral dose of 200 mg AMG 986. |
| Name | Type | Description |
|---|---|---|
| AMG 986 | DRUG | tablets for oral administration |
Inclusion Criteria: * Male or female subjects, who are \> or = 18 and \< or = 65 years of age at the time of screening * Subject has provided informed consent prior to initiation of any study-specific activities/procedures * Women must be of non-reproductive potential (ie, postmenopausal, history o...