Bioequivalence Study of Idalopirdine in Healthy Subjects

November 10, 2016 updated by: H. Lundbeck A/S

Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 10 mg Commercial Tablet (Test) to the 10 mg Clinical Tablet (Reference)

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test/Reference
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)
single dose, 10 mg, oral
Drug: Idalopirdine clinical tablet (reference)
single dose, 10 mg, oral
Experimental: Reference/Test
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)
single dose, 10 mg, oral
Drug: Idalopirdine clinical tablet (reference)
single dose, 10 mg, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose
Time Frame: baseline to 72 hours post-dose
baseline to 72 hours post-dose
Maximum observed concentration of idalopirdine (Cmax)
Time Frame: baseline to 72 hours post-dose
baseline to 72 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to occurrence of Cmax (tmax)
Time Frame: baseline to 72 hours post-dose
baseline to 72 hours post-dose
Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity
Time Frame: baseline to 72 hours post-dose
baseline to 72 hours post-dose
Apparent elimination half-life (t1/2)
Time Frame: baseline to 72 hours post-dose
baseline to 72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 16976A
  • 2016-000405-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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