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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05391724 | Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects | PHASE1 | COMPLETED | 25 | — | — | Feb 1, 2011 | Sep 1, 2011 | May 26, 2022 | 3 | United States |
An objective of this study was to determine the safety following administration of a single dose of CMX001 in subjects with moderate and severe hepatic impairment compared to match subjects with normal hepatic function.
| Arm | Type | Description |
|---|---|---|
| CMX001 | EXPERIMENTAL | single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg |
| Name | Type | Description |
|---|---|---|
| CMX001 | DRUG | single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg |
Inclusion Criteria: 1. Able to comprehend and willing to sign an informed consent form (ICF); 2. Male or female subjects, between 18 and 65 years of age, inclusive; 3. Within body mass index (BMI) range 18 to 40 kg/m2, inclusive; 4. Negative test for selected drugs of abuse at Screening (does not i...