Phase I trial: Parexel International Ltd. Code: 20628A
| ISRCTN | ISRCTN81314354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81314354 |
| Integrated Research Application System (IRAS) | 1011008 |
| Sponsor code | 20628A |
| Sponsor | H. Lundbeck A/S |
| Funder | H. Lundbeck A/S |
- Submission date
- 17/07/2026
- Registration date
- 21/07/2026
- Last edited
- 21/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Pablo Forte Soto
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
Parexel International Ltd
Parexel Early Phase Clinical Unit
Northwick Park Hospital
Harrow
HA1 3UJ
United Kingdom
| Phone | +44 1895 614 883 |
|---|---|
| HarrowVolunteerFeedback@parexel.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | 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. |
| Purpose | 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. |
| Scientific title | Phase I trial: Parexel International Ltd. Code: 20628A |
| 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 27/01/2025, South Central - Berkshire B Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8276; berkshireb.rec@hra.nhs.uk), ref: 24/SC/0334 |
| 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 | Not Specified |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 08/07/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 84 |
| Total final enrolment | 78 |
| 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 | 19/02/2025 |
| Date of final enrolment | 15/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Parexel Early Phase Clinical Unit
Northwick Park Hospital
Harrow
HA1 3UJ
England
Harrow
HA1 3UJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
17/07/2026: Trial's existence confirmed by MHRA.
