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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04246749 | Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers | PHASE1 | COMPLETED | 11 | — | — | Sep 17, 2019 | Oct 25, 2019 | Jan 29, 2020 | 1 | Netherlands |
| NCT03276858 | Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers | PHASE1 | COMPLETED | 99 | — | — | Sep 22, 2017 | Apr 30, 2018 | Aug 29, 2018 | 1 | Australia |
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...