Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528665
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Determine PK Profiles of Ozanimod and Its Major Metabolites in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pharmacokinetic Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system TDS patch to achieve better drug absorption and delivery than via oral capsules Zeposia Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics tolerability and safety Participants will either take one capsule only or wear a patch on hisher arm for 7 days and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed
Detailed Description:
This is a single-dose single-center open-label randomized parallel relative bioavailability study 4 treatments and 1 period of 3 test products of a Transdermal Delivery System of Ozanimod Corplex Ozanimod TDS with the Reference Listed Drug Zeposia Capsule 092 mg recruiting around 24 healthy male female 11 subjects under fasting conditions
The following goals will be procured through this study
1 To determine the pharmacokinetic profiles of Ozanimod and its major metabolites CC112273 and CC1084037 from the Corplex Ozanimod TDS OZ-TDS 1 OZ-TDS 2 and OZ-TDS 3 manufactured by Corium Innovations Inc Test Product 1 Test Product 2 and Test Product 3 and the comparator Zeposia Capsule 092 mg manufactured by Bristol Myers Squibb Reference Product in healthy subjects
2 To compare the relative bioavailability between the Corplex Ozanimod TDS and the oral capsules in healthy subjects
3 To compare three formulations of the Corplex Ozanimod TDS in healthy subjects
4 To determine the safety and tolerability of the Corplex Ozanimod TDS vs the oral capsules in healthy subjects
The following goals will be procured through this study
1 To determine the pharmacokinetic profiles of Ozanimod and its major metabolites CC112273 and CC1084037 from the Corplex Ozanimod TDS OZ-TDS 1 OZ-TDS 2 and OZ-TDS 3 manufactured by Corium Innovations Inc Test Product 1 Test Product 2 and Test Product 3 and the comparator Zeposia Capsule 092 mg manufactured by Bristol Myers Squibb Reference Product in healthy subjects
2 To compare the relative bioavailability between the Corplex Ozanimod TDS and the oral capsules in healthy subjects
3 To compare three formulations of the Corplex Ozanimod TDS in healthy subjects
4 To determine the safety and tolerability of the Corplex Ozanimod TDS vs the oral capsules in healthy subjects
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