D2 Dopamine Receptor Occupancy After Oral Dosing of Lu AF35700 in Healthy Men Using [11C]-PHNO as Tracer Compound

Phase 1CompletedNCT02093169

H. Lundbeck A/S12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Men

Interventions

Part A: Lu AF35700DRUG

One 30 mg single dose for one day; orally

Part B: Lu AF35700DRUG

Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally

Eligibility

Sex: MALEMin age: 25 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GB801

London, United Kingdom

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

Time frame: Up to Week 12

Columbia Suicide Severity Rating Scale (C-SSRS) (Part B only)

Time frame: Up to Week 12

Area under the curve (AUC), maximum observed concentration (Cmax), oral clearance (CL/F), and apparent elimination half-life (t½)

Time frame: Up to 168 hours after dosing

Data from ClinicalTrials.gov

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