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OpenTrials
Completed

NCT Number: NCT02093169

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

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

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Key information

Conditions

Healthy Men

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GB801

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Part A: Lu AF35700

Drug

One 30 mg single dose for one day; orally

Part B: Lu AF35700

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Adverse events

    Time frame: Up to Week 12

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

    Time frame: Up to Week 12

  3. 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
First posted
Mar 20, 2014
Registry last updated
Sep 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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