Cariprazine: Comparison of Slow- and Immediate-release Forms

Study Overview
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Brief Summary
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The investigators are doing this study to compare blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. The investigators will also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Detailed Description
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Comparison of blood levels and side effects of cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate release' capsule. We'll also find out if food affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.

Official Title
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A Single-Dose Study to Evaluate the Pharmacokinetic, Safety, Tolerability Profile and the Effects of Food on the Pharmacokinetics of Different Formulations of Cariprazine in Healthy Male Subjects

Conditions
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Pharmacokinetic Profile

Intervention / Treatment
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* Drug: Cariprazine prolonged release tablet A
* Drug: Cariprazine prolonged release tablet B
* Drug: Cariprazine capsule
* Drug: Cariprazine PR tablet A
* Drug: Cariprazine PR tablet B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Caucasian males aged 18-55 years with body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2 Have a semisupine pulse rate ≥ 40 bpm and ≤ 100 bpm during the vital sign assessment at screening and on admission (Day 1) Agree to use an effective method of contraception and not have their partners become pregnant throughout the study and for up to 4 months after the administration of the IMP, or have been sterilized for at least 1 year Exclusion Criteria: -

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

Sexes Eligible for Study
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Male

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cariprazine PR tablet B<br>Cariprazine prolonged release tablet B - fed | Drug: Cariprazine PR tablet B<br>* Cariprazine Prolonged Release tablet B - fed<br>|
| Experimental: Cariprazine PR tablet A<br>Cariprazine prolonged release tablet A - fed | Drug: Cariprazine PR tablet A<br>* Cariprazine Prolonged Release tablet A - fed<br>|
| Experimental: Cariprazine capsule<br>Cariprazine capsule - fasted | Drug: Cariprazine capsule<br>* Cariprazine capsule - fasted<br>|
| Experimental: Cariprazine prolonged release tablet B<br>Cariprazine prolonged release tablet B - fasted | Drug: Cariprazine prolonged release tablet B<br>* Cariprazine prolonged release tablet B - fasted<br>|
| Experimental: Cariprazine prolonged release tablet A<br>Cariprazine prolonged release tablet A - fasted | Drug: Cariprazine prolonged release tablet A<br>* Cariprazine prolonged release tablet A - fasted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C[max] | Maximum Serum Concentration of the parent drug | 0-672 hours | 
| AUC | Area Under the Serum Concentration-Time Curve of the parent drug | 0-672 hours | 
| T[max] | Time to Reach the Maximum Serum Concentration of the parent drug | 0-672 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other PK parameters of the parent drug | Elimination half-life period (t1/2), Mean Residence Time (MRT), if applicable | 0-672 hours | 
| PK parameters of the metabolites, if applicable | Maximum Serum Concentration (Cmax), Time to Reach the Maximum Serum Concentration (Tmax), (AUC0-t), Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC0-∞), Elimination half-life period (t1/2) and Mean Residence Time (MRT) | 0-672 hours |