Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
2
This study is a phase I trial to investigate the effect of inhibition of CYP3A4/5 by Erythromycin on the pharmacokinetics of CHF6001 in healthy volunteers.
Key facts
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 27 Mar 2024 → 18 Jun 2024
- Decision date (initial)
- 2024-02-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
This study is a phase I trial to investigate the effect of inhibition of CYP3A4/5 by Erythromycin on the pharmacokinetics of CHF6001 in healthy volunteers.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chiesi Farmaceutici S.p.A.
- Sponsor organisation
- Chiesi Farmaceutici S.p.A.
- Address
- Via Palermo 26 A
- City
- Parma
- Postcode
- 43122
- Country
- Italy
Scientific contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVELOPMENT
Public contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVELOPMENT
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 24 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2024-03-27 | 2024-06-18 | 2024-03-28 | 2024-05-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-14 | Bulgaria | Acceptable 2024-02-09
|
2024-02-12 |