Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118684
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-10-20
Brief Title:
Clinical Trial to Assess Effect of Verapamil on Systemic Exposure of EP395 and Effect of EP395 on Systemic Exposure of Midazolam and Digoxin
Sponsor:
EpiEndo Pharmaceuticals
Organization:
EpiEndo Pharmaceuticals
Study Overview
Official Title:
An Open-label Healthy Subject Two-part Study to Assess the Effect of Verapamil on Systemic Exposure of EP395 Part A and to Assess the Effect of EP395 on Systemic Exposure of Midazolam and Digoxin Part B
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The aim of this trial is to assess the potential key drug-drug interactions with EP395 in the clinical setting
Detailed Description:
This is an open-label healthy subject two-part study to assess the effect of verapamil on systemic exposure of EP395 Part A and to assess the effect of EP395 on systemic exposure of midazolam and digoxin Part B
The overall aim of this trial is to assess the potential key drug-drug interactions DDIs with EP395 in the clinical setting The trial will be in two parts
Part A will investigate EP395 as a victim of DDIs The impact of CYP3A4 and P-glycoprotein Pgp inhibition on the pharmacokinetics PK of EP395 will be assessed Verapamil has been selected as a moderate inhibitor of CYP3A4 and an inhibitor of Pgp
Part B will investigate EP395 as a perpetrator of DDIs The impact of EP395 on the PK of a CYP3A4 substrate and a Pgp substrate will be assessed Midazolam has been selected as the CYP3A4 substrate and digoxin as the Pgp substrate
The trial population is healthy adults
The overall aim of this trial is to assess the potential key drug-drug interactions DDIs with EP395 in the clinical setting The trial will be in two parts
Part A will investigate EP395 as a victim of DDIs The impact of CYP3A4 and P-glycoprotein Pgp inhibition on the pharmacokinetics PK of EP395 will be assessed Verapamil has been selected as a moderate inhibitor of CYP3A4 and an inhibitor of Pgp
Part B will investigate EP395 as a perpetrator of DDIs The impact of EP395 on the PK of a CYP3A4 substrate and a Pgp substrate will be assessed Midazolam has been selected as the CYP3A4 substrate and digoxin as the Pgp substrate
The trial population is healthy adults
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