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

H. Lundbeck A/S6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

[ethyl-1-14C]-idalopirdineDRUG

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

[benzyl-7-14C]-idalopirdineDRUG

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

Eligibility

Sex: MALEMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GB802

Leeds, United Kingdom

Outcomes

Primary Outcomes

Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)

Time frame: 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)

PK parameter:

Time frame: 0 to 168 hours

Data from ClinicalTrials.gov

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