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A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the absorption, distribution, metabolism, excretion, and mass balance of orally administered radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808 administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: [14C]-CRN00808 Oral Solution | Experimental | Single oral dose of CRN00808 containing [14C]-CRN00808 |
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| Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer | Experimental | Single oral dose of CRN00808 followed by [14C]-CRN00808 IV microtracer injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-CRN00808 | Drug | Investigational drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance of CRN00808 | Total radioactivity in urine and feces following a single oral dose [14C]-CRN00808 (expressed as a percentage of the total radioactive dose administered) | Up to 21 days (until >90% of dose is recovered) |
| Absolute bioavailability of CRN00808 | Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of CRN00808 and [14C]-CRN00808 | Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7 |
| Pharmacokinetics (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | Netherlands |
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| CRN00808 | Drug | Investigational drug |
|
Assessment of the total elimination half-life of CRN00808 and [14C]-CRN00808
| Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7 |
| Pharmacokinetics (Tmax) | Assessment of Time to attain maximum observed plasma concentration of CRN00808 and [14C]-CRN00808 | Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7 |
| Pharmacokinetics (CL) | Assessment of the clearance of CRN00808 (Part B only) | Day 1 through to Day 7 |
| Pharmacokinetics (CL/F) | Assessment of Apparent oral clearance of CRN00808 | Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7 |
| Pharmacokinetics (Vz) | Assessment of Volume of distribution at terminal phase (Part B only) | Day 1 through to Day 7 |
| Pharmacokinetics (Vz/F) | Assessment of Apparent volume of distribution at terminal phase | Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7 |