Skip to main content
OpenTrials
Completed

NCT Number: NCT02415907

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GB802

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[ethyl-1-14C]-idalopirdine

Drug

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

Other names: Lu AF67708

[benzyl-7-14C]-idalopirdine

Drug

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

Other names: Lu AF67709

Primary outcomes

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

    Time frame: 0 to 168 hours

  2. 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:

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2015
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.