Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CRN00808 · 2 trials · 1 indication
Total radioactivity in urine and feces following a single oral dose \[14C\]-CRN00808 (expressed as a percentage of the total radioactive dose administered)
Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration
ECG, clinical laboratory parameters, vital signs, physical examinations, telemetry, Holter monitoring
ECG, clinical laboratory parameters, vital signs, physical examinations
| Arm | Type | Description |
|---|---|---|
| Part A: [14C]-CRN00808 Oral Solution | EXPERIMENTAL | Single oral dose of CRN00808 containing \[14C\]-CRN00808 |
| Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer | EXPERIMENTAL | Single oral dose of CRN00808 followed by \[14C\]-CRN00808 IV microtracer injection |
| CRN00808 Oral Solution | EXPERIMENTAL | CRN00808 oral solution, single-dose |
| CRN00808 Oral Capsule | EXPERIMENTAL | CRN00808 oral capsule, single-dose and multiple-doses |
| Placebo Oral Solution | PLACEBO_COMPARATOR | Placebo oral solution, single-dose |
| Placebo Oral Capsule | PLACEBO_COMPARATOR | Placebo oral capsule, single-dose and multiple doses |
| Midazolam Oral Solution | OTHER | Midazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study |
| Name | Type | Description |
|---|---|---|
| [14C]-CRN00808 | DRUG | Investigational drug |
| CRN00808 | DRUG | Investigational drug |
| Placebo Oral Solution | DRUG | Placebo |
| Midazolam oral solution | DRUG | Midazolam as part of the drug-drug interaction arm of the study |
| Placebo oral capsule | DRUG | Placebo |
Inclusion Criteria: 1. Male subjects 19 to 55 years of age 2. BMI 18 to 30 kg/m2 Exclusion Criteria: 1. Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metab...
CRN00808 is an investigational small molecule being studied in healthy volunteers. It has been evaluated in Phase 1 clinical trials to assess its safety, tolerability, and pharmacokinetics. The drug is not approved for any indication and remains in clinical development.
CRN00808 is being developed by Crinetics Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRNX. The company has sponsored Phase 1 clinical trials of the drug in healthy volunteers.
CRN00808 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
CRN00808 has been studied in two completed Phase 1 trials. NCT03276858 was a single and multiple-ascending dose study in 99 healthy volunteers in Australia. NCT04246749 was a mass balance and pharmacokinetics study of [14C]-CRN00808 in 11 healthy male volunteers in the Netherlands.
CRN00808 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials in healthy volunteers. The drug remains in clinical development and has not been authorized for marketing.