Cariprazine: Comparison of Slow- and Immediate-release Forms

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02165098

Enrollment

160

Registered

2014-06-17

Start date

2014-06-30

Completion date

2016-02-29

Last updated

2016-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic Profile

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.

Interventions

DRUGCariprazine prolonged release tablet A

Cariprazine prolonged release tablet A - fasted

DRUGCariprazine prolonged release tablet B

Cariprazine prolonged release tablet B - fasted

DRUGCariprazine capsule

Cariprazine capsule - fasted

DRUGCariprazine PR tablet A

Cariprazine Prolonged Release tablet A - fed

DRUGCariprazine PR tablet B

Cariprazine Prolonged Release tablet B - fed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026