Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-CRN00808, Paltusotine
CRN00808 · 5 trials · 11 indications
Treatment group difference of change from baseline to Week 12 in flushing episodes/day averaged over the 14 days prior to Week 12.
Change from baseline in IGF-1 level at Week 13/End of Treatment (W13/EoT) in Group 1 subjects Efficacy Analysis Set (EAS).
Proportion of subjects who meet responder criteria (based on the mean of two consecutive IGF-1 measurements ≤ upper limit of normal \[ULN\])
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 |
|---|---|---|
| Paltusotine 80 mg daily | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Paltusotine | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| Paltusotine | DRUG | Experimental Drug: Randomized |
| Placebo | DRUG | Matching Placebo Drug: Randomized |
| [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: * Male or female ≥18 years of age, at the time of Screening. * Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period. * Documented carcinoid syndrome requiring medical thera...
CRN00808 is an investigational small molecule developed by Crinetics Pharmaceuticals, Inc. (ticker CRNX). It has been studied in Phase 1 clinical trials in healthy volunteers, including a single and multiple-ascending dose study and a mass balance and pharmacokinetics study. The specific therapeutic indication for CRN00808 has not been disclosed.
CRN00808 targets somatostatin receptor type 2, a receptor. This molecular target places it in the receptor-targeting class of small molecule therapeutics. The drug is designed to interact with this receptor, though its clinical applications remain under investigation.
CRN00808 is being developed by Crinetics Pharmaceuticals, Inc., a company publicly traded under the ticker symbol CRNX. Crinetics is responsible for the research and clinical development of this investigational small molecule.
CRN00808 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Two Phase 1 trials have been completed, and no active trials are currently listed.
CRN00808 has been evaluated in two completed Phase 1 trials: NCT04246749, a mass balance and pharmacokinetics study in healthy volunteers in the Netherlands, and NCT03276858, a single and multiple-ascending dose study in healthy volunteers in Australia. Both trials are completed.
Yes, [14C]-CRN00808 is an alternative name for CRN00808. The [14C] label indicates a carbon-14 radiolabeled version used in a mass balance study (NCT04246749) to track the drug's absorption, distribution, metabolism, and excretion in healthy volunteers.