Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04991181
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2021-07-28
Brief Title:
Absorption Distribution Metabolism and Excretion of BIA 5-1058
Sponsor:
Bial - Portela C SA
Organization:
Bial - Portela C SA
Study Overview
Official Title:
An Open-label Study to Assess the Absorption Distribution Metabolism and Excretion Including the Mass Balance of 14C Labeled BIA 5-1058 and Metabolites Following a Single Oral Dose Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2021-07
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:
ADME
Brief Summary:
the purpose of this study is
to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine feces and exhaled air after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 37 Megabecquerel MBq of radiocarbon
to determine the pharmacokinetics PK of total radioactivity TRA in plasma and whole blood and to assess the blood-to-plasma ratio
to determine the PK of BIA 5-1058 and its metabolites in plasma
to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine feces and exhaled air after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 37 Megabecquerel MBq of radiocarbon
to determine the pharmacokinetics PK of total radioactivity TRA in plasma and whole blood and to assess the blood-to-plasma ratio
to determine the PK of BIA 5-1058 and its metabolites in plasma
Detailed Description:
This was a Phase 1 single-center open-label absorption distribution metabolism and excretion study in 8 healthy adult male subjects Subjects received a single oral dose of 400 mg BIA 5-1058 containing approximately 37 MBq 008 milliSievert mSv of 14C-BIA 5-1058 as oral capsules Screening was between Day -21 and Day -2 and confinement period was of one period in the clinic involving drug administration on Day 1 with admission on Day 1 and discharge on Day 15 336 hours post-dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-002407-28 | EUDRACT_NUMBER | None | None |