Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205381
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-12-19
Brief Title:
Assessment of the Safety Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers
Sponsor:
Aeovian Pharmaceuticals Inc
Organization:
Aeovian Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Single And Multiple Ascending Dose Food Effect and Drug-Drug Interaction Study With Itraconazole Midazolam and Fexofenadine Of Orally Administered AV078 In Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This Phase 1 study in healthy adult volunteers is planned to evaluate the safety tolerability and pharmacokinetics PK of AV078 a selective inhibitor of mammalian target of rapamycin complex 1 mTORC1
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose SAD and multiple ascending dose MAD cohorts Subsequent cohorts will collect PK data to evaluate food effects and potential drug-drug interactions relevant to AV078
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose SAD and multiple ascending dose MAD cohorts Subsequent cohorts will collect PK data to evaluate food effects and potential drug-drug interactions relevant to AV078
Detailed Description:
This Phase 1 study in healthy adult volunteers is planned to evaluate the safety tolerability and pharmacokinetics PK of AV078 a selective inhibitor of mammalian target of rapamycin complex 1 mTORC1 The study will additionally explore the relationship between AV078 and pharmacodynamic biomarkers related to mTOR
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose SAD and multiple ascending dose MAD cohorts incorporating reviews by a dedicated Safety Review Group to guide dose escalation decisions The study will also include a cohort using a 2-way crossover design to evaluate food effects on the PK of AV078 The study will additionally include cohorts evaluating potential drug-drug-interactions DDIs using coadministration of index substrates and index perpetrators typically used in DDI studies of the relevant enzymes Specifically one DDI cohort will assess the effects of administration of itraconazole a strong inhibitor of CYP3A4 on the PK of AV078 and an additional DDI cohort will assess the effects of administration of AV078 on the PK of midazolam a sensitive probe substrate for CYP3A4 and fexofenadine a probe substrate for P-gp
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose SAD and multiple ascending dose MAD cohorts incorporating reviews by a dedicated Safety Review Group to guide dose escalation decisions The study will also include a cohort using a 2-way crossover design to evaluate food effects on the PK of AV078 The study will additionally include cohorts evaluating potential drug-drug-interactions DDIs using coadministration of index substrates and index perpetrators typically used in DDI studies of the relevant enzymes Specifically one DDI cohort will assess the effects of administration of itraconazole a strong inhibitor of CYP3A4 on the PK of AV078 and an additional DDI cohort will assess the effects of administration of AV078 on the PK of midazolam a sensitive probe substrate for CYP3A4 and fexofenadine a probe substrate for P-gp
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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