NCT02371707

Brief Summary

This study aims to establish bioequivalence between two tablet formulations of idalopirdine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 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

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

February 20, 2015

Last Update Submit

May 6, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the idalopirdine plasma concentration-time curve

    0 to 72 hours post-dose

  • maximum observed concentration (Cmax) of idalopirdine

    0 to 72 hours post-dose

Study Arms (2)

Idalopirdine 60 mg formulation A (test)

EXPERIMENTAL
Drug: Idalopirdine 60 mg formulation A (test)

Idalopirdine 60 mg formulation B (reference)

EXPERIMENTAL
Drug: Idalopirdine 60 mg formulation B (reference)

Interventions

Idalopirdine 60 mg formulation A (test)DRUG

Tablet for oral use, single dose

Also known as: Lu AE58054
Idalopirdine 60 mg formulation A (test)
Idalopirdine 60 mg formulation B (reference)DRUG

Tablet for oral use, single dose

Also known as: Lu AE58054
Idalopirdine 60 mg formulation B (reference)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • ≥18 and ≤55 years of age
  • body mass index (BMI) of \>18.5 and \<30 kg/m2

You may not qualify if:

  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Leeds, United Kingdom

Location

MeSH Terms

Interventions

(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

GB(1)