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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02415907

Enrollment

Registered

2015-04-14

Start date

2015-04-30

Completion date

2015-06-30

Last updated

2015-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUG[ethyl-1-14C]-idalopirdine

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

DRUG[benzyl-7-14C]-idalopirdine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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:

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026