Phase I trial: Parexel code: PXL 269850
| ISRCTN | ISRCTN12117857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12117857 |
| EudraCT/CTIS number | 2022-003322-50 |
| IRAS number | 1006840 |
| Secondary identifying numbers | IRAS 1006840, PXL 269850, NMD1343-01-0001 |
- Submission date
- 29/06/2023
- Registration date
- 29/06/2023
- Last edited
- 30/04/2025
- 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
Principal Investigator
Parexel Early Phase Clinical Unit
Harrow
HA1 3UJ
United Kingdom
| Phone | +44 (0)7548098654 |
|---|---|
| david.steel@parexel.com |
Study information
| Study design | Phase I first-in-human study to assess safety, tolerability and pharmacokinetics in healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I trial: Parexel code: PXL 269850 [The full scientific title will be published within 30 months after the end of the trial] |
| 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) |
1. Approved 09/02/2023, London - Harrow Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom; +44 (0)207 104 8154; harrow.rec@hra.nhs.uk), ref: 23/LO/0007 2. Approved 21/02/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 57479/0001/001-0001 |
| 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 |
| Pharmaceutical study type(s) | Pharmacokinetic |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The sponsor has confirmed that the trial meets the criteria for 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 20/12/2022 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 88 |
| 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 | 21/03/2023 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Watford Road
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Industry
Palle Juul-Jensens Boulevard 82
Aarhus
8200
Denmark
| Phone | +45 (0)31 76 40 56 |
|---|---|
| contact@nmdpharma.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/11/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this Phase I study and the negligible benefit to the public of Phase I information. Results will be posted on or after the date of publication of full trial details. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the study being conducted in healthy volunteers |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
30/04/2025: EudraCT/CTIS number and a secondary identifying number were added.
20/09/2023: A link to the HRA research summary was added.
29/06/2023: Study's existence confirmed by the MHRA.
