Deferred registration - Fortrea Clinical Research Unit Code: NMD670-01-0002
| ISRCTN | ISRCTN17493503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17493503 |
| Integrated Research Application System (IRAS) | 1014907 |
| Protocol number | NMD670-01-0002 |
| Sponsor | NMD Pharma A/S (Denmark) |
| Funder | NMD Pharma A/S (Denmark) |
- Submission date
- 16/10/2026
- Registration date
- 02/11/2026
- Last edited
- 02/11/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Principal investigator
Fortrea Clinical Research Unit
Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom
Leeds
LS11 9EH
United Kingdom
| Phone | +44 1133013512 |
|---|---|
| Benjamin.Monaghan@fortrea.com |
Public, Scientific
Palle Juul-Jensens Boulevard 82
Aarhus N
DK-8200
Denmark
| contact@nmdpharma.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Phase 1 clinical pharmacology/ADME and mass-balance study. |
| Scientific title | A phase 1, open-label, nonrandomized trial to evaluate the absorption, metabolism, excretion (AME) and mass balance of [14C]NMD670 in healthy male participants |
| Study objectives | 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. |
| Ethics approval(s) |
Submitted 23/09/2026, London – Central Research Ethics Committee (REC) (2 Redman Place, Stratford, London, E201JQ, United Kingdom; +44 207 104 8197; londoncentral.rec@hra.nhs.uk), ref: 26/LO/07/19 |
| 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) |
|
| Key secondary outcome measure(s) | |
| Completion date | 25/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 55 Years |
| Sex | Male |
| Target sample size at registration | 8 |
| 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 | 23/11/2026 |
| Date of final enrolment | 10/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom
Leeds
LS11 9EH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
19/10/2026: Study’s existence confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA), UK.
