Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
36
Countries
1
Sites
1
Post-Traumatic Stress Disorder (PTSD)
Key facts
- Sponsor
- Rest Therapeutics
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03], Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2023-07-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Post-Traumatic Stress Disorder (PTSD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036316 | Post-traumatic stress disorder | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rest Therapeutics
- Sponsor organisation
- Rest Therapeutics
- Address
- 105 Place Eugene Bataillon
- City
- Montpellier Cedex 5
- Postcode
- 34095
- Country
- France
Scientific contact point
- Organisation
- Rest Therapeutics
- Contact name
- Chief Medical Officer Dr Florent Perin-Dureau
Public contact point
- Organisation
- Rest Therapeutics
- Contact name
- Chief Medical Officer Dr Florent Perin-Dureau
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Not authorised | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-22 | Belgium | Not acceptable 2023-07-10
|
2023-07-11 |