Phase 1 Trial: CSD241701
| ISRCTN | ISRCTN50947231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50947231 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 344408 |
| Protocol serial number | CSD241701 |
| Sponsor | Reynolds American (United States) |
| Funder | Reynolds American Inc. Services |
- Submission date
- 17/11/2024
- Registration date
- 18/11/2024
- Last edited
- 18/11/2024
- 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
401 N. Main Street
Winston-Salem
27101
United States of America
| Phone | +1 336-259-1200 |
|---|---|
| gibsona1@rjrt.com |
Scientific
990 Dulin Road
Mocksville
27028
United States of America
| Phone | +1 336-413-1542 |
|---|---|
| curedfour@protonmail.com |
Principal investigator
22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom
| Phone | +44 (0)2890 554047 |
|---|---|
| devinda.weeraratne@celerion.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-centre randomized cross-over trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Phase 1 Trial: CSD241701 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) |
Approved 18/07/2024, Office for Research and Ethics Committee Northern Ireland (Business Services Organisation Unit 4, Lissue Industrial Estate West, Rathdown Walk, Moira Road, Lisburn, Belfast, BT28 2RF, United Kingdom; +44 (0)28 9536 1400; info.orecni@hscni.net), ref: 24-NI-0077 |
| 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 | Other |
| 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 | 26/08/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 42 |
| 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 | 19/07/2024 |
| Date of final enrolment | 19/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Belfast
BT9 6AD
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 during and/or analysed during the current study are not expected to be made available due to the protection of commercially confidential information |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/11/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).
