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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415907
• Other study ID #: 15836A
• Secondary ID: 2013-004001-28
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2015
• Last updated: July 17, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	GB802	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative amounts of radioactivity excreted in urine and faeces (% of dose)		0 to 168 hours	No
Primary	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:	0 to 168 hours	No