Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Brincidofovir, BCV, Hexadecyloxypropyl cidofovir, HDP-CDV
CMX001 · 1 trial · 1 indication
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...
CMX001 is being studied in hepatic impairment, a condition in which liver function is reduced. The clinical program has focused on evaluating the drug in people with impaired hepatic function as well as healthy subjects. It is an investigational small molecule and has not been approved for any use.
CMX001 is being developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker JAZZ. The company is the sponsor of the clinical program evaluating the drug in hepatic impairment. Jazz Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing medicines in areas including gastrointestinal and neuroscience.
CMX001 is in Phase 1 clinical development. Its single recorded trial was a Phase 1 study, and no later-phase studies in hepatic impairment have been recorded. Because it remains investigational, CMX001 is not approved by the FDA for any indication and is still being evaluated in clinical research.
CMX001 has been evaluated in one completed Phase 1 trial, NCT05391724, titled Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects. The study enrolled 25 participants in the United States, included healthy volunteers, and was an uncontrolled, non-randomized design. No active trials are currently listed.
The completed Phase 1 study NCT05391724 assessed the safety and pharmacokinetics of CMX001 in people with impaired hepatic function and in healthy subjects. It enrolled 25 participants aged 18 years and older of all sexes in the United States. The trial was uncontrolled, not randomized, and not double blinded.