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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093169
• Other study ID #: 15868A
• Secondary ID: 2013-004283-61
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2014
• Last updated: September 22, 2014
• Start date: February 2014

Study information

• Verified date: September 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Men

Intervention

Drug:
• Part A: Lu AF35700
One 30 mg single dose for one day; orally
• Part B: Lu AF35700
Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally

Locations

Country	Name	City	State
United Kingdom	GB801	London

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

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