Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615284
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Study of Atorvo in Healthy Adult Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Single-Blind Three-Arm Staggered Parallel Study to Assess the Safety Tolerability and Pharmacokinetics of Atorvo in Healthy Adult Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
A Phase 1 study will assess the safety tolerability and pharmacokinetics of Atorvo in healthy adult participants
Detailed Description:
This study will be testing an approved dose of atorvastatin 40 mg and doses of CBD in the approved range 100 mg and 200 mg approximately 17 mgkgday and 33 mgkgday for a 60 kg patient respectively in the study
A total of 24 participants are planned to be enrolled into 3 study arms Eight 8 participants are planned to be randomized in each of Arms 1 2 and 3 Each arm will consist of a 28-days Screening period a 28-day treatment period and a 14-day follow-up period Investigational products IPs refer to all study treatments and will be administered at the following planned dose levels
Arm 1 Atorvastatin generic formulation oral tablet 40 mg once daily for 28 days
Arm 2 Atorvo Low 40 mg Atorvastatin and 100 mg CBD once daily for 28 days
Arm 3 Atorvo High 40 mg Atorvastatin and 200 mg CBD once daily for 28 days
A total of 24 participants are planned to be enrolled into 3 study arms Eight 8 participants are planned to be randomized in each of Arms 1 2 and 3 Each arm will consist of a 28-days Screening period a 28-day treatment period and a 14-day follow-up period Investigational products IPs refer to all study treatments and will be administered at the following planned dose levels
Arm 1 Atorvastatin generic formulation oral tablet 40 mg once daily for 28 days
Arm 2 Atorvo Low 40 mg Atorvastatin and 100 mg CBD once daily for 28 days
Arm 3 Atorvo High 40 mg Atorvastatin and 200 mg CBD once daily for 28 days
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