Skip to main content
OpenTrials
Completed

NCT Number: NCT02165098

Cariprazine: Comparison of Slow- and Immediate-release Forms

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacokinetic Profile

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Cariprazine prolonged release tablet A

Drug

Cariprazine prolonged release tablet A - fasted

Cariprazine prolonged release tablet B

Drug

Cariprazine prolonged release tablet B - fasted

Cariprazine capsule

Drug

Cariprazine capsule - fasted

Cariprazine PR tablet A

Drug

Cariprazine Prolonged Release tablet A - fed

Cariprazine PR tablet B

Drug

Cariprazine Prolonged Release tablet B - fed

Primary outcomes

  1. C[max]

    Time frame: 0-672 hours

    Maximum Serum Concentration of the parent drug

  2. AUC

    Time frame: 0-672 hours

    Area Under the Serum Concentration-Time Curve of the parent drug

  3. T[max]

    Time frame: 0-672 hours

    Time to Reach the Maximum Serum Concentration of the parent drug

Secondary outcomes

  1. Other PK parameters of the parent drug

    Time frame: 0-672 hours

    Elimination half-life period (t1/2), Mean Residence Time (MRT), if applicable

  2. PK parameters of the metabolites, if applicable

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Gedeon Richter Plc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2014
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.