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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy young men >=25 and <=45 years of age with a Body Mass Index (BMI) >=18.5 kg/m2 and <=30 kg/m
- •Other protocol-defined Inclusion and
Exclusion Criteria
- Not provided
Arms & Interventions
Part A: Lu AF35700
Intervention: Part A: Lu AF35700 (Drug)
Part B: Lu AF35700
Intervention: Part B: Lu AF35700 (Drug)
Outcomes
Primary Outcomes
Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point
Time Frame: Up to 172 hours after dosing
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
Time Frame: Up to 172 hours after dosing
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
Time Frame: Up to 172 hours after dosing
Secondary Outcomes
- Adverse events(Up to Week 12)
- Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only)(Up to Week 12)
- 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)