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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [ethyl-1-14C]-idalopirdine; Drug: [benzyl-7-14C]-idalopirdine

• Registration Number: NCT02415907
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-14
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-17
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Idalopirdine	[ethyl-1-14C]-idalopirdine	Period I: Initial administration of Lu AF67709 single dose at baseline. Period II: Administration of Lu AF67708 single dose (week 4)
Idalopirdine	[benzyl-7-14C]-idalopirdine	Period I: Initial administration of Lu AF67709 single dose at baseline. Period II: Administration of Lu AF67708 single dose (week 4)

Primary Outcome Measures

Name	Time	Method
Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)	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)	0 to 168 hours	PK parameter:

Trial Locations

Locations (1)

GB802; 🇬🇧 Leeds, United Kingdom