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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Men

Treatments: Drug: Part A: Lu AF35700; Drug: Part B: Lu AF35700

Study type: Interventional

Funder types: Industry

Identifiers

NCT02093169

2013-004283-61 (EudraCT Number)

15868A

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Part A: Lu AF35700

Experimental group

Treatment:

Drug: Part A: Lu AF35700

Part B: Lu AF35700

Experimental group

Treatment:

Drug: Part B: Lu AF35700