NCT02093169

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Last Updated

September 23, 2014

Status Verified

September 1, 2014

Enrollment Period

4 months

First QC Date

March 19, 2014

Last Update Submit

September 22, 2014

Conditions

Healthy Men

Outcome Measures

Primary Outcomes (3)

  • Relationship between plasma concentrations and pharmacodynamic (PD) measures specified as binding potential at each scanning time point

    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

    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

    Up to 172 hours after dosing

Secondary Outcomes (3)

  • 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

Study Arms (2)

Part A: Lu AF35700

EXPERIMENTAL
Drug: Part A: Lu AF35700

Part B: Lu AF35700

EXPERIMENTAL
Drug: Part B: Lu AF35700

Interventions

Part A: Lu AF35700DRUG

One 30 mg single dose for one day; orally

Part A: Lu AF35700
Part B: Lu AF35700DRUG

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

Part B: Lu AF35700

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young men \>=25 and \<=45 years of age with a Body Mass Index (BMI) \>=18.5 kg/m2 and \<=30 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GB801

London, NW10 7EW, United Kingdom

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 20, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Last Updated

September 23, 2014

Record last verified: 2014-09

Locations

GB(1)