Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
1
Pharmacokinetic trial in healthy volunteers
Key facts
- Sponsor
- Universitaetsklinikum Heidelberg AöR
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03], Phenomena and Processes [G] - Biological Phenomena [G16]
- Trial duration
- 11 Sep 2024 → 3 Mar 2026
- Decision date (initial)
- 2024-09-02
- 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
Pharmacokinetic trial in healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Heidelberg AöR
- Sponsor organisation
- Universitaetsklinikum Heidelberg AöR
- Address
- Im Neuenheimer Feld 672, Neuenheim Neuenheim
- City
- Heidelberg
- Postcode
- 69120
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Heidelberg AöR
- Contact name
- Clinical Trial Unit (Internal Medicine IX, Department Clinical Pharmacology & Pharmacoepidemiology)
Public contact point
- Organisation
- Universitaetsklinikum Heidelberg AöR
- Contact name
- Clinical Trial Unit (Internal Medicine IX, Department Clinical Pharmacology & Pharmacoepidemiology)
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Internal Medicine IX: Department of Clinical Pharmacology and Pharmacoepidemiology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
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 |
|---|---|---|---|---|---|
| Germany | 2024-09-11 | 2024-10-01 | 2026-03-03 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | Germany | Acceptable 2024-08-28
|
2024-09-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-29 | Germany | Acceptable 2024-12-23
|
2024-12-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-22 | Germany | Acceptable 2025-05-14
|
2025-05-19 |