Healthy Men Clinical Trial
Official title:
Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound
To investigate the relationship between the combined Lu AF35700 and Lu AF36152 plasma concentration and D2 dopamine receptor occupancy up to 172 hours after oral dosing of Lu AF35700
Status | Completed |
Enrollment | 12 |
Est. completion date | |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy young men >=25 and <=45 years of age with a Body Mass Index (BMI) >=18.5 kg/m2 and <=30 kg/m2. Other protocol-defined Inclusion and Exclusion criteria may apply. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | GB801 | London |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point | Up to 172 hours after dosing | No | |
Primary | Relationship between plasma concentrations and PD measures specified as plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152 at each scanning time point | Up to 172 hours after dosing | No | |
Primary | Relationship between plasma concentrations and PD measures specified as occupancy in relation to plasma concentrations of Lu AF35700, Lu AF36152 and Lu AF35700 + Lu AF36152, respectively | Up to 172 hours after dosing | No | |
Secondary | Adverse events | Up to Week 12 | Yes | |
Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only) | Up to Week 12 | Yes | |
Secondary | Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½) | Up to 168 hours after dosing | No |
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