Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
101
Countries
1
Sites
1
Acromegaly
Key facts
- Sponsor
- Amolyt Pharma, Amolyt Pharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 26 May 2023 → 23 Apr 2024
- Decision date (initial)
- 2023-04-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acromegaly
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10000599 | Acromegaly | 100000004860 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amolyt Pharma
- Sponsor organisation
- Amolyt Pharma
- Address
- Building G Espace Europeen, 15 Chemin Du Saquin 15 Chemin Du Saquin
- City
- Ecully
- Postcode
- 69130
- Country
- France
Scientific contact point
- Organisation
- Amolyt Pharma
- Contact name
- Principal Investigator - ICON
Public contact point
- Organisation
- Amolyt Pharma
- Contact name
- Principal Investigator - ICON
Amolyt Pharma
- Sponsor organisation
- Amolyt Pharma
- Address
- Building G Espace Europeen, 15 Chemin Du Saquin 15 Chemin Du Saquin
- City
- Ecully
- Postcode
- 69130
- Country
- France
Scientific contact point
- Organisation
- Amolyt Pharma
- Contact name
- Principal Investigator - ICON
Public contact point
- Organisation
- Amolyt Pharma
- Contact name
- Principal Investigator - ICON
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 101 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-05-26 | 2024-04-23 | 2023-05-26 | 2024-03-08 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-20 | Netherlands | Acceptable 2023-04-24
|
2023-04-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-06-21 | Netherlands | Acceptable 2023-04-24
|
2023-06-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-25 | Netherlands | Acceptable 2023-08-28
|
2023-08-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-06 | Netherlands | Acceptable with conditions 2023-12-22
|
2023-12-22 |