Deferred registration: Fortrea code: 776181

ISRCTN	ISRCTN72930441
DOI	https://doi.org/10.1186/ISRCTN72930441
Integrated Research Application System (IRAS)	1013923
Sponsor	Lundbeck (Denmark)
Funder	H. Lundbeck A/S

Submission date: 08/07/2026
Registration date: 09/07/2026
Last edited: 09/07/2026

Recruitment status: Not yet 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

This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date

Contact information

Dr Firas Almazedi
Public, Scientific, Principal investigator

Drapers Yard, Marshall St, Holbeck
Leeds
LS11 9EH
United Kingdom

Phone	+441133013642
Email	firas.almazedi@fortrea.com

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Pharmacokinetic
Scientific title	Deferred registration: Fortrea code: 776181 [Full scientific title to be added on or before the deferral expiry date]
Study objectives
Ethics approval(s)	Approved 18/06/2026, East of England - Cambridge Central Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; N/A; cambridgecentral.rec@hra.nhs.uk), ref: 26/EE/0100
Health condition(s) or problem(s) studied	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date
Intervention	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date
Primary outcome measure(s)	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date. [Outcome] measured using [measure] at [timepoint]
Key secondary outcome measure(s)
Completion date	20/11/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	0 Years
Upper age limit	1 Year
Sex	All
Target sample size at registration	32
Key inclusion criteria	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date
Key exclusion criteria	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date
Date of first enrolment	15/07/2026
Date of final enrolment	09/10/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Fortrea Clinical Research Unit

Drapers Yard, Marshall St, Holbeck
Leeds
LS11 9EH
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

09/07/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).