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CMX001 · 2 trials · 2 indications
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 |
| 1 | EXPERIMENTAL | All subjects will receive three 40mg doses of CMX001 as 1)solution fasted, 2)tablet fasted and 3)tablet following a high-fat breakfast. The order in which each subject receives each of the doses will be determined by a randomization code. |
| 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 an investigational small molecule being studied in healthy volunteers and in subjects with hepatic impairment. It is currently in Phase 1 clinical development, with completed trials evaluating its safety, pharmacokinetics, and bioavailability. The drug is not approved and remains under investigation.
CMX001 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy subjects and those with hepatic impairment.
CMX001 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy volunteers and one in subjects with hepatic impairment. The drug is investigational and has not been approved by regulatory authorities.
CMX001 has completed two Phase 1 trials. NCT00780182 evaluated comparative bioavailability and the effect of food in healthy volunteers, enrolling 24 participants. NCT05391724 assessed safety and pharmacokinetics in subjects with impaired hepatic function and healthy subjects, enrolling 25 participants. Both trials were conducted in the United States.
CMX001 is also known as brincidofovir, an antiviral small molecule. It is being developed by Jazz Pharmaceuticals for potential use in treating viral infections, though the current Phase 1 trials focus on healthy volunteers and subjects with hepatic impairment.