Cariprazine: Comparison of Slow- and Immediate-release Forms

Phase 1

Completed

• Conditions: Pharmacokinetic Profile
• Interventions: Drug: Cariprazine PR tablet A; Drug: Cariprazine prolonged release tablet B; Drug: Cariprazine PR tablet B; Drug: Cariprazine capsule; Drug: Cariprazine prolonged release tablet A

• Registration Number: NCT02165098
• Lead Sponsor: Gedeon Richter Plc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-17
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cariprazine PR tablet A	Cariprazine PR tablet A	Cariprazine prolonged release tablet A - fed
Cariprazine prolonged release tablet B	Cariprazine prolonged release tablet B	Cariprazine prolonged release tablet B - fasted
Cariprazine PR tablet B	Cariprazine PR tablet B	Cariprazine prolonged release tablet B - fed
Cariprazine capsule	Cariprazine capsule	Cariprazine capsule - fasted
Cariprazine prolonged release tablet A	Cariprazine prolonged release tablet A	Cariprazine prolonged release tablet A - fasted

Primary Outcome Measures

Name	Time	Method
C[max]	0-672 hours	Maximum Serum Concentration of the parent drug
AUC	0-672 hours	Area Under the Serum Concentration-Time Curve of the parent drug
T[max]	0-672 hours	Time to Reach the Maximum Serum Concentration of the parent drug

Secondary Outcome Measures

Name	Time	Method
Other PK parameters of the parent drug	0-672 hours	Elimination half-life period (t1/2), Mean Residence Time (MRT), if applicable
PK parameters of the metabolites, if applicable	0-672 hours	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)

Trial Locations

Locations (1)

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom