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
2 other identifiers
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 24, 2016
March 1, 2016
1.7 years
June 13, 2014
March 23, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
C[max]
Maximum Serum Concentration of the parent drug
0-672 hours
AUC
Area Under the Serum Concentration-Time Curve of the parent drug
0-672 hours
T[max]
Time to Reach the Maximum Serum Concentration of the parent drug
0-672 hours
Secondary Outcomes (2)
Other PK parameters of the parent drug
0-672 hours
PK parameters of the metabolites, if applicable
0-672 hours
Study Arms (5)
Cariprazine PR tablet B
EXPERIMENTALCariprazine prolonged release tablet B - fed
Cariprazine PR tablet A
EXPERIMENTALCariprazine prolonged release tablet A - fed
Cariprazine capsule
EXPERIMENTALCariprazine capsule - fasted
Cariprazine prolonged release tablet B
EXPERIMENTALCariprazine prolonged release tablet B - fasted
Cariprazine prolonged release tablet A
EXPERIMENTALCariprazine prolonged release tablet A - fasted
Interventions
Cariprazine prolonged release tablet A - fasted
Cariprazine prolonged release tablet B - fasted
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hammersmith Medicines Research
London, NW10 7EW, United Kingdom
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 17, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 24, 2016
Record last verified: 2016-03