Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05006118
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2021-07-28
Brief Title:
Pharmacokinetics and Excretion of Oral 14C-Rodatristat Ethyl
Sponsor:
Altavant Sciences GmbH
Organization:
Altavant Sciences GmbH
Study Overview
Official Title:
An Open-Label Mass Balance Study to Investigate the Pharmacokinetics Excretion and Recovery of Single-Dose Oral 14C-Rodatristat Ethyl in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label study to evaluate the PK and excretion of a single oral dose of 14C-rodatristat ethyl The study will consist of Screening evaluations within 29 days prior to dosing a treatment phase from dosing until discharge from the unit a minimum of 7 days and a maximum of 14 days and discharge procedures
Detailed Description:
This is an open-label study to evaluate the PK and excretion of a single oral dose of 14C-rodatristat ethyl The study will consist of Screening evaluations within 29 days prior to dosing a treatment phase from dosing until discharge from the unit a minimum of 7 days and a maximum of 14 days and discharge procedures
After meeting eligibility criteria approximately 6 healthy male subjects will check into the clinical unit Day -1 and the following morning receive a single oral suspension of rodatristat ethyl 600 mg containing a mixture of 12C-rodatristat ethyl and 14C-rodatristat ethyl to contain approximately 600 microcuries μCi of radioactivity Day 1 After fasting 10 hours overnight the dose will be administered with a standard-calorie meal Following dosing serial whole blood and plasma PK samples and urine and feces will be collected until discharge Subjects will stay in the clinic until at least Day 7 Subjects will be discharged if total recovery urine and feces combined of the administered radioactive dose is 90 and the total daily recovery of radioactive dose is 1 on 2 consecutive days in which a fecal sample is collected If not subjects will remain in the clinic until these criteria are met but not longer than 15 days which includes Day -1 Plasma and urine samples will be analyzed for total radioactivity rodatristat ethyl rodatristat M15 and any other identified metabolites if applicable Blood and fecal samples will be analyzed for total radioactivity rodatristat ethyl rodatristat and metabolites
After meeting eligibility criteria approximately 6 healthy male subjects will check into the clinical unit Day -1 and the following morning receive a single oral suspension of rodatristat ethyl 600 mg containing a mixture of 12C-rodatristat ethyl and 14C-rodatristat ethyl to contain approximately 600 microcuries μCi of radioactivity Day 1 After fasting 10 hours overnight the dose will be administered with a standard-calorie meal Following dosing serial whole blood and plasma PK samples and urine and feces will be collected until discharge Subjects will stay in the clinic until at least Day 7 Subjects will be discharged if total recovery urine and feces combined of the administered radioactive dose is 90 and the total daily recovery of radioactive dose is 1 on 2 consecutive days in which a fecal sample is collected If not subjects will remain in the clinic until these criteria are met but not longer than 15 days which includes Day -1 Plasma and urine samples will be analyzed for total radioactivity rodatristat ethyl rodatristat M15 and any other identified metabolites if applicable Blood and fecal samples will be analyzed for total radioactivity rodatristat ethyl rodatristat and metabolites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None