ISRCTN ISRCTN50947231
DOI https://doi.org/10.1186/ISRCTN50947231
IRAS number 344408
Secondary identifying numbers CSD241701
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
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.

Study website

Contact information

Ms Gwyn Gibson
Public

401 N. Main Street
Winston-Salem
27101
United States of America

Phone +1 336-259-1200
Email gibsona1@rjrt.com
Dr Gregory Tarleton
Scientific

990 Dulin Road
Mocksville
27028
United States of America

Phone +1 336-413-1542
Email curedfour@protonmail.com
Dr Devinda Weeraratne
Principal Investigator

22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom

Phone +44 (0)2890 554047
Email devinda.weeraratne@celerion.com

Study information

Study designInterventional single-centre randomized cross-over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeSafety, Efficacy
Scientific titlePhase 1 Trial: CSD241701 The full scientific title will be published within 30 months after the end of the trial
Study objectivesThe 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) studiedThe 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.
InterventionThe 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 typeOther
Primary outcome measureThe 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 measuresThe 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 date01/05/2024
Completion date26/08/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit21 Years
Upper age limit60 Years
SexBoth
Target number of participants42
Key inclusion criteriaThe 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 criteriaThe 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 enrolment19/07/2024
Date of final enrolment19/08/2024

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Celerion Belfast
22-24 Lisburn Rd, Belfast
Belfast
BT9 6AD
United Kingdom

Sponsor information

Reynolds American (United States)
Industry

401 North Main Street
Winston-Salem
27101
United States of America

Phone +1 336-741-2000
Email gibsona1@rjrt.com
Website https://www.reynoldsamerican.com/
ROR logo "ROR" https://ror.org/05qcjd272

Funders

Funder type

Industry

Reynolds American Inc. Services

No information available

Results and Publications

Intention to publish date31/12/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe 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.
IPD sharing planThe 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

Editorial Notes

18/11/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).