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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [ethyl-1-14C]-idalopirdine; Drug: [benzyl-7-14C]-idalopirdine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02415907

2013-004001-28 (EudraCT Number)

15836A

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Idalopirdine

Experimental group

Description:

Period I: Initial administration of Lu AF67709 single dose at baseline. Period II: Administration of Lu AF67708 single dose (week 4)

Treatment:

Drug: [ethyl-1-14C]-idalopirdine

Drug: [benzyl-7-14C]-idalopirdine