Cariprazine: Comparison of Slow- and Immediate-release Forms

Gedeon Richter

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic Profile

Treatments: Drug: Cariprazine PR tablet A; Drug: Cariprazine prolonged release tablet A; Drug: Cariprazine PR tablet B; Drug: Cariprazine prolonged release tablet B; Drug: Cariprazine capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02165098

RGH-188-101

2013-004925-99 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 5 patient groups

Cariprazine PR tablet B

Experimental group

Description:

Cariprazine prolonged release tablet B - fed

Treatment:

Drug: Cariprazine PR tablet B

Cariprazine PR tablet A

Experimental group

Description:

Cariprazine prolonged release tablet A - fed

Treatment:

Drug: Cariprazine PR tablet A

Cariprazine capsule

Experimental group

Description:

Cariprazine capsule - fasted

Treatment:

Drug: Cariprazine capsule

Cariprazine prolonged release tablet B

Experimental group

Description:

Cariprazine prolonged release tablet B - fasted

Treatment:

Drug: Cariprazine prolonged release tablet B

Cariprazine prolonged release tablet A

Experimental group

Description:

Cariprazine prolonged release tablet A - fasted

Treatment:

Drug: Cariprazine prolonged release tablet A