Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395610
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-04-29
Brief Title:
Effect of Erythromycin on the Absorption Metabolism and Elimination of CHF6001 in Healthy Volunteers
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
Open-label Non-randomised One-sequence Crossover Study to Investigate the Effect of Inhibition of CYP3A45 by Erythromycin on the Pharmacokinetics of CHF6001 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-07
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 objective of this study is to investigate the effect of the interaction of Erythromycin CYP3A45 moderate inhibitor on the pharmacokinetic of CHF6001 CYP3A45 substrate in Healthy Volunteers
Detailed Description:
This clinical trial is a single centre single dose Phase I study with a non-randomized open label one sequence cross-over design
A total of 24 healthy male and female are planned to be included Participants will be dosed with CHF6001 before and during co-administration of Erythromycin and will act as their own control The study will be run with a one-sequence crossover design where all subjects will be treated with CHF6001 in the first treatment period and CHF6001 Erythromycin in the second treatment period in order to avoid the need of a very long washout from the CYP3A45 inhibitor
Standard safety assessments will be conducted during the Study including safety blood and urine laboratory tests vital signs physical examinations ECGs and observations of any adverse events Blood samples will be also collected for PK analysis
A total of 24 healthy male and female are planned to be included Participants will be dosed with CHF6001 before and during co-administration of Erythromycin and will act as their own control The study will be run with a one-sequence crossover design where all subjects will be treated with CHF6001 in the first treatment period and CHF6001 Erythromycin in the second treatment period in order to avoid the need of a very long washout from the CYP3A45 inhibitor
Standard safety assessments will be conducted during the Study including safety blood and urine laboratory tests vital signs physical examinations ECGs and observations of any adverse events Blood samples will be also collected for PK analysis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507300-30-00 | CTIS | None | None |