Bioequivalence Study of Lu AF35700

Study Overview
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Brief Summary
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The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg

Official Title
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Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AF35700 5 mg clinical formulation
* Drug: Lu AF35700 5 mg commercial formulation
* Drug: Lu AF35700 10 mg clinical formulation
* Drug: Lu AF35700 10 mg commercial formulation
* Drug: Lu AF35700 20 mg clinical formulation
* Drug: Lu AF35700 20 mg commercial formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women aged ≥18 and ≤55 years Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2 Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination Exclusion Criteria: The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser The subject has previously been dosed with Lu AF35700 Other protocol defined inclusion and exclusion criteria may apply

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: Lu AF35700 5 mg clinical formulation<br> | Drug: Lu AF35700 5 mg clinical formulation<br>* Lu AF35700 tablets 5 mg oral single dose<br>|
| Experimental: Lu AF35700 5 mg commercial formulation<br> | Drug: Lu AF35700 5 mg commercial formulation<br>* Lu AF35700 tablets 5 mg oral single dose<br>|
| Experimental: Lu AF35700 10 mg clinical formulation<br> | Drug: Lu AF35700 10 mg clinical formulation<br>* Lu AF35700 tablets 10 mg oral single dose<br>|
| Experimental: Lu AF35700 10 mg commercial formulation<br> | Drug: Lu AF35700 10 mg commercial formulation<br>* Lu AF35700 tablets 10 mg oral single dose<br>|
| Experimental: Lu AF35700 20 mg clinical formulation<br> | Drug: Lu AF35700 20 mg clinical formulation<br>* Lu AF35700 tablets 20 mg oral single dose<br>|
| Experimental: Lu AF35700 20 mg commercial formulation<br> | Drug: Lu AF35700 20 mg commercial formulation<br>* Lu AF35700 tablets 20 mg oral single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-72h of Lu AF35700 | Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h) | zero to 72 hours | 
| Cmax of Lu AF35700 | Maximum observed plasma concentration (Cmax) of Lu AF35700 | zero to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of Lu AF35700 | Time to occurance of Cmax of Lu AF35700 | zero to 72 hours | 
| AUC0-t of Lu AF35700 | Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration | zero to time of the last quantifiable plasma concentration |