Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764851
Status:
TERMINATED
Last Update Posted:
2021-05-24
First Post:
2021-01-18
Brief Title:
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
Sponsor:
Emalex Biosciences Inc
Organization:
Emalex Biosciences Inc
Study Overview
Official Title:
A Phase 1 Open-Label Fixed Sequence Drug-Drug Interaction Study to Evaluate the Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A number of subjects withdrew consent leaving the study without adequate power to achieve its primary end points
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center open-label fixed sequence Phase 1 drug-drug interaction DDI study in healthy subjects
Detailed Description:
Following a screening period of up to 28 days subjects will be admitted to the clinical research unit into one of three cohorts On the morning of Day 1 subjects in cohorts 1 2 and 3 will receive fasted doses of probe substrates per assigned cohort On Day 5 Cohort 2 only will receive a second fasted dose of probe substrates Subjects in cohorts 1 2 and 3 will receive the final fasted dose of probe substrates on Day 13 Fasted ecopipam administration will begin on Day 5 and will continue through Day 17 at 2mgkg for all cohorts Ecopipam doses will be tapered starting on Day 18 by 25 mgday increments until subjects are off drug with final discharge occurring 24 hours after the ecopipam HCl dose has been reduced to 25 mg Day 21 23 or 25
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