Ignite Creation Date:
2024-05-06 @ 7:16 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02508740
Status:
TERMINATED
Last Update Posted:
2015-07-27
First Post:
2015-07-22
Brief Title:
Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment
Sponsor:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
Phase 1 Non-Randomized Parallel-Group Open-Label Study to Characterize the Pharmacokinetics of a Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment Compared to Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Development of compound has been put on hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to characterize the effect of renal function on the PK of a 025 mg single oral dose of bevenopran in humans and to assess the safety and tolerability of bevenopran in patients with varying degrees of renal impairment and in healthy subjects
Detailed Description:
The current Food and Drug Administration FDA draft guidance for renal impairment studies advises performance of a PK study in patients with renal impairment for medications primarily excreted in urine and also for medications primarily metabolized or secreted in bile The major routes of excretion of bevenopran in animals were identified as hepatobiliary and renal In addition preliminary findings show 40 of an oral bevenopran dose is eliminated unchanged in urine over a 48-72 hour period post-dose
This is a Phase 1 non-randomized parallel group open-label study to characterize the effect of renal function on the PK of bevenopran in 1 or more study centers At screening eligible subjects will be enrolled and assigned to 1 of 5 parallel study groups of approximately 8 to 12 subjects each based on the classification of the renal function using estimated glomerular filtration rate eGFR from the Modification of Diet in Renal Disease MDRD Study as presented in the FDA guidance on renal impairment studies There are 5 study groups based on eGFRs
This is a Phase 1 non-randomized parallel group open-label study to characterize the effect of renal function on the PK of bevenopran in 1 or more study centers At screening eligible subjects will be enrolled and assigned to 1 of 5 parallel study groups of approximately 8 to 12 subjects each based on the classification of the renal function using estimated glomerular filtration rate eGFR from the Modification of Diet in Renal Disease MDRD Study as presented in the FDA guidance on renal impairment studies There are 5 study groups based on eGFRs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None