Phase I trial: Fortrea Clinical Pharmacology Services 1006539
| ISRCTN | ISRCTN28892128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28892128 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1006539 |
| Protocol serial number | IRAS 1006539 |
| Sponsor | Idorsia Pharmaceuticals Ltd |
| Funder | Idorsia Pharmaceuticals Ltd |
- Submission date
- 06/12/2022
- Registration date
- 07/12/2022
- Last edited
- 16/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Public, Scientific, Principal investigator
Hegenheimermattweg 91
Allschwil
4123
Switzerland
| Phone | +41 58 844 1977 |
|---|---|
| idorsiaclinicaltrials@idorsia.com |
Principal investigator
Fortrea Clinical Research Unit Ltd
Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 113 394 5200 |
|---|---|
| jim.bush@fortrea.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | First-in-man safety, pharmacokinetics and pharmacodynamics trial in 106 healthy volunteers. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Phase I trial: Fortrea Clinical Pharmacology Services 1006539 |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) | Approved 24/11/2022, North East – York Research Ethics Committee, NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44 (0)207 104 8079; york.rec@hra.nhs.uk; ref: 22/NE/0204. The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Primary outcome measure(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key secondary outcome measure(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 04/06/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 106 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 06/12/2022 |
| Date of final enrolment | 03/05/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Holbeck
Leeds
LS11 9EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/07/2025: The following changes were made:
1. The completion date was changed from 30/06/2024 to 04/06/2024.
2. The date of final enrolment was changed from 30/06/2024 to 03/05/2024.
3. The intention to publish date was changed from 31/12/2026 to 04/12/2026.
31/03/2025: Publication reference added.
24/03/2025: Internal review.
10/01/2025: Internal review.
19/12/2023: The following changes were made to the study record:
1. The public title was changed from 'Phase I trial: Labcorp Clinical Pharmacology Services 1006539' to 'Phase I trial: Fortrea Clinical Pharmacology Services 1006539'.
2. The scientific title was changed from 'Phase I trial: Labcorp Clinical Pharmacology Services 1006539' to 'Phase I trial: Fortrea Clinical Pharmacology Services 1006539'.
3. Contact details and study participating centre address updated.
4. The recruitment end date was changed from 31/12/2023 to 30/06/2024.
5. The overall study end date was changed from 31/12/2023 to 30/06/2024.
6. The intention to publish date was changed from 30/06/2026 to 31/12/2026.
13/11/2023: A contact was removed.
28/06/2023: A contact was added.
07/12/2022: Trial's existence confirmed by North East – York Research Ethics Committee.
