Cariprazine: Comparison of Slow- and Immediate-release Forms

Pharmacokinetic Profile Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165098
• Other study ID #: RGH-188-101
• Secondary ID: 2013-004925-99
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2014
• Last updated: March 23, 2016
• Start date: June 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Gedeon Richter Plc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetic Profile

Intervention

Drug:
• Cariprazine prolonged release tablet A
Cariprazine prolonged release tablet A - fasted
• Cariprazine prolonged release tablet B
Cariprazine prolonged release tablet B - fasted
• Cariprazine capsule
Cariprazine capsule - fasted
• Cariprazine PR tablet A
Cariprazine Prolonged Release tablet A - fed
• Cariprazine PR tablet B
Cariprazine Prolonged Release tablet B - fed

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Gedeon Richter Plc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C[max]	Maximum Serum Concentration of the parent drug	0-672 hours	No
Primary	AUC	Area Under the Serum Concentration-Time Curve of the parent drug	0-672 hours	No
Primary	T[max]	Time to Reach the Maximum Serum Concentration of the parent drug	0-672 hours	No
Secondary	Other PK parameters of the parent drug	Elimination half-life period (t1/2), Mean Residence Time (MRT), if applicable	0-672 hours	No
Secondary	PK parameters of the metabolites, if applicable	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 (AUC0-8), Elimination half-life period (t1/2) and Mean Residence Time (MRT)	0-672 hours	No