Cariprazine: Comparison of Slow- and Immediate-release Forms

March 23, 2016 updated by: Gedeon Richter Plc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW10 7EW
        • Hammersmith Medicines Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C[max]
Time Frame: 0-672 hours
Maximum Serum Concentration of the parent drug
0-672 hours
AUC
Time Frame: 0-672 hours
Area Under the Serum Concentration-Time Curve of the parent drug
0-672 hours
T[max]
Time Frame: 0-672 hours
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
Time Frame: 0-672 hours
Elimination half-life period (t1/2), Mean Residence Time (MRT), if applicable
0-672 hours
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)
0-672 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gedeon Richter Plc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-188-101
  • 2013-004925-99 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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