Bioequivalence Study of Idalopirdine in Healthy Subjects

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: Idalopirdine commercial tablet (test)
* Drug: Idalopirdine clinical tablet (reference)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Reference<br>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)<br>* single dose, 10 mg, oral<br>Drug: Idalopirdine clinical tablet (reference)<br>* single dose, 10 mg, oral<br>|
| Experimental: Reference/Test<br>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)<br>* single dose, 10 mg, oral<br>Drug: Idalopirdine clinical tablet (reference)<br>* single dose, 10 mg, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |