Healthy Male Volunteers
Conditions
Brief summary
The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 (\[14C\]) GRT6019
Detailed description
This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.
Interventions
DRUG[14C]GRT6019
Single administration in a single dosing period.
Sponsors
Grünenthal GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers 2. Aged 30 to 65 years inclusive at the time of signing informed consent
Exclusion criteria
1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 3. Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs 4. History of clinically significant cardiovascular, renal, hepatic, respiratory, particularly gastrointestinal (GI) disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's disease or irritable bowel syndrome, neurological or psychiatric disorder, or clinically significant dermatological disorder 5. History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative amount of total radioactivity excreted (CumAe) | Day -1 (Admission), Day 1 up to Days 47-48. | To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of \[14C\]GRT6019 |
| Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae) | Day -1 (Admission), Day 1 up to Days 47-48. | To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of \[14C\]GRT6019 |
| Metabolite profling and structural identification | Day -1 (Admission), Day 1 up to Days 47-48. | To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples |
Countries
United Kingdom
Outcome results
None listed