NCT02894515

Brief Summary

The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

Same day

First QC Date

September 5, 2016

Last Update Submit

November 10, 2016

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (2)

  • Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose

    baseline to 72 hours post-dose

  • Maximum observed concentration of idalopirdine (Cmax)

    baseline to 72 hours post-dose

Secondary Outcomes (3)

  • Time to occurrence of Cmax (tmax)

    baseline to 72 hours post-dose

  • Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity

    baseline to 72 hours post-dose

  • Apparent elimination half-life (t1/2)

    baseline to 72 hours post-dose

Study Arms (2)

Test/Reference

EXPERIMENTAL

Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days

Drug: Idalopirdine commercial tablet (test)Drug: Idalopirdine clinical tablet (reference)

Reference/Test

EXPERIMENTAL

Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days

Drug: Idalopirdine commercial tablet (test)Drug: Idalopirdine clinical tablet (reference)

Interventions

Idalopirdine commercial tablet (test)DRUG

single dose, 10 mg, oral

Reference/TestTest/Reference
Idalopirdine clinical tablet (reference)DRUG

single dose, 10 mg, oral

Reference/TestTest/Reference

Eligibility Criteria

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

You may qualify if:

  • Healthy men and women with a body mass index (BMI) of \>18.5 and \<30 kg/m2.

You may not qualify if:

  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GB1050

Leeds, United Kingdom

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR
0

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

September 5, 2016

First Posted

September 9, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 11, 2016

Record last verified: 2016-11

Locations

GB(1)