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

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ClinicalTrials.gov Identifier: NCT02415907
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: [ethyl-1-14C]-idalopirdine Drug: [benzyl-7-14C]-idalopirdine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Idalopirdine

Period I: Initial administration of Lu AF67709 single dose at baseline.

Period II: Administration of Lu AF67708 single dose (week 4)

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

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




Primary Outcome Measures :
  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:



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415907


Locations
United Kingdom
GB802
Leeds, United Kingdom
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck LuncbeckClinicalTrials@Lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02415907     History of Changes
Other Study ID Numbers: 15836A
2013-004001-28 ( EudraCT Number )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015