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

July 17, 2015 updated by: H. Lundbeck A/S

Interventional, Open-label, Two Single Dose, Fixed-sequence Study Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine Following a Single Oral Dose of Lu AF67708 ([Ethyl-1-14C]-Idalopirdine) and Lu AF67709 ([Benzyl-7-14C]-Idalopirdine) in Healthy Men

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Other protocol defined inclusion and exclusion criteria do apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Idalopirdine

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

Period II: Administration of Lu AF67708 single dose (week 4)
Drug: [ethyl-1-14C]-idalopirdine
120 mg/2.40 MBq Lu AF67708 ([ethyl-1-14C]-idalopirdine) in one capsule for oral administration, single dose
Other Names:
  • Lu AF67708
Drug: [benzyl-7-14C]-idalopirdine
120 mg/2.40 MBq Lu AF67709 ([benzyl-7-14C]-idalopirdine) in one capsule for oral administration, single dose
Other Names:
  • Lu AF67709

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)
Time Frame: 0 to 168 hours
0 to 168 hours
Pharmacokinetic (PK) of idalopirdine and radioactivity in plasma (Cmax, tmax, AUC, t1/2, oral clearance and apparant volume of distribution. (composite outcome measure)
Time Frame: 0 to 168 hours
PK parameter:
0 to 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck, LuncbeckClinicalTrials@Lundbeck.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

July 20, 2015

Last Update Submitted That Met QC Criteria

July 17, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 15836A
  • 2013-004001-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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