NCT02415907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

April 7, 2015

Last Update Submit

July 17, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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)

    PK parameter:

    0 to 168 hours

Study Arms (1)

Idalopirdine

EXPERIMENTAL

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]-idalopirdineDrug: [benzyl-7-14C]-idalopirdine

Interventions

[ethyl-1-14C]-idalopirdineDRUG

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

Also known as: Lu AF67708
Idalopirdine
[benzyl-7-14C]-idalopirdineDRUG

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

Also known as: Lu AF67709
Idalopirdine

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • aged between 40-60 years (inclusive)
  • BMI in the range 19 and 30 kg/m2 (minimum weight 60 kg)

You may not qualify if:

  • The subject has previously been dosed with idalopirdine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GB802

Leeds, United Kingdom

Location

Study Officials

  • Email contact via H. Lundbeck

    LuncbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 14, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations

GB(1)