* Study of Pharmacokinetics, Mass Balance and Metabolite Profiles of NRD135S.E1 (QSC203557)
Research type
Research Study
Full title
Open-Label Study to Investigate Pharmacokinetics, Mass Balance and Metabolite Profiles of NRD135S.E1 in Healthy Adult Male Volunteers
IRAS ID
1004636
Contact name
Eva Tiecke
Contact email
Sponsor organisation
Novaremed AG
Eudract number
2021-006502-76
ISRCTN Number
ISRCTN51059297
Research summary
The Sponsor is developing the test medicine, NRD135S.E1, for the potential treatment of painful diabetic peripheral neuropathy (PDPN). Peripheral neuropathy develops over time because high blood sugar levels associated with diabetes can damage the nerves in the body which can lead to spontaneous pain.
This healthy volunteer study will try to assess how the test medicine is taken up, processed and removed by the body when given as an oral solution at steady state. To help investigate how this happens, the test medicine will be radiolabelled. ‘Radiolabelled’ means the test medicine has a radioactive component (Carbon-14), which enables the test medicine to be tracked in the body. The safety and tolerability of the test medicine will also be studied.
This study will take place at one non-NHS site and will consist of a single study period involving 8 healthy male volunteers aged 30-65.
On Days 1 to 13, volunteers will receive single doses of the non-radiolabelled test medicine in the form of an oral capsule, in the morning. On Day 7, 30 minutes following the non-radiolabelled dose, volunteers will receive a single dose of the radiolabelled test medicine in the form of an oral solution.
Volunteers will be dosed after breakfast every day. Blood samples will be taken throughout the study for analysis of the test medicine and for safety. Saliva, urine and faecal collection will begin after the radiolabelled dose. Volunteers will stay in the clinic up to Day 14. If relevant radioactivity criteria have not been met, the stay may be extended until Day 16. If relevant criteria are still not met at this point, home collections of urine and/or faeces may be required.
Volunteers are expected to be involved in this study for approximately 7 weeks from screening to the follow-up call.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/FT/0015
Date of REC Opinion
22 Feb 2022
REC opinion
Further Information Favourable Opinion