Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foliglurax | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foliglurax | Drug | Single oral dose of 80 mg [14C]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from [14C]-foliglurax powder for oral solution) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of radioactivity excreted | Cumulative amount of radioactivity excreted in urine and faeces | Before dosing until day 11 |
| AUC(0-inf) foliglurax | Area under the plasma concentration time curve from zero to infinity | From day 1 until day 11 |
| Cmax foliglurax | Maximum observed plasma concentration | From day 1 until day 11 |
| CL/F foliglurax | Oral clearance for foliglurax in plasma | From Day 1 until Day 11 |
| Total recovery of the administered dose | % of dose in urine and faeces | Before dosing until day 11 |
Not provided
Not provided
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 exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GB1050 Covance | Leeds | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000730045 | foliglurax |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided