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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. 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.

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


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
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