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

NCT ID: NCT02093169

Last Updated: 2014-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Men

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Lu AF35700

Group Type EXPERIMENTAL

Part A: Lu AF35700

Intervention Type DRUG

One 30 mg single dose for one day; orally

Part B: Lu AF35700

Group Type EXPERIMENTAL

Part B: Lu AF35700

Intervention Type DRUG

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

Interventions

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Part A: Lu AF35700

One 30 mg single dose for one day; orally

Intervention Type DRUG

Part B: Lu AF35700

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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GB801

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2013-004283-61

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15868A

Identifier Type: -

Identifier Source: org_study_id

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