Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine

NCT ID: NCT02415907

Last Updated: 2015-07-20

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose of this study is to investigating the absorption, metabolism and excretion of radio labelled single doses of idalopirdine in healthy men.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Idalopirdine

Period I: Initial administration of Lu AF67709 single dose at baseline.

Period II: Administration of Lu AF67708 single dose (week 4)

Group Type EXPERIMENTAL

[ethyl-1-14C]-idalopirdine

Intervention Type DRUG

120 mg/2.40 MBq Lu AF67708 (\[ethyl-1-14C\]-idalopirdine) in one capsule for oral administration, single dose

[benzyl-7-14C]-idalopirdine

Intervention Type DRUG

120 mg/2.40 MBq Lu AF67709 (\[benzyl-7-14C\]-idalopirdine) in one capsule for oral administration, single dose

Interventions

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[ethyl-1-14C]-idalopirdine

120 mg/2.40 MBq Lu AF67708 (\[ethyl-1-14C\]-idalopirdine) in one capsule for oral administration, single dose

Intervention Type DRUG

[benzyl-7-14C]-idalopirdine

120 mg/2.40 MBq Lu AF67709 (\[benzyl-7-14C\]-idalopirdine) in one capsule for oral administration, single dose

Intervention Type DRUG

Other Intervention Names

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Lu AF67708 Lu AF67709

Eligibility Criteria

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Inclusion Criteria

* Healthy men
* aged between 40-60 years (inclusive)
* BMI in the range 19 and 30 kg/m2 (minimum weight 60 kg)

Exclusion Criteria

* The subject has previously been dosed with idalopirdine.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 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

Role: STUDY_DIRECTOR

[email protected]

Locations

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GB802

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2013-004001-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15836A

Identifier Type: -

Identifier Source: org_study_id

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