Healthy
Conditions
Brief summary
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.
Detailed description
Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.
Interventions
DRUGFoliglurax
Single oral dose of 80 mg \[14C\]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from \[14C\]-foliglurax powder for oral solution)
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit.
Exclusion criteria
\- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of radioactivity excreted | Before dosing until day 11 | Cumulative amount of radioactivity excreted in urine and faeces |
| AUC(0-inf) foliglurax | From day 1 until day 11 | Area under the plasma concentration time curve from zero to infinity |
| Cmax foliglurax | From day 1 until day 11 | Maximum observed plasma concentration |
| CL/F foliglurax | From Day 1 until Day 11 | Oral clearance for foliglurax in plasma |
| Total recovery of the administered dose | Before dosing until day 11 | % of dose in urine and faeces |
Countries
United Kingdom
Outcome results
None listed