Pharmacokinetic ProfilePhase 1NCT02165098
Cariprazine: Comparison of Slow- and Immediate-release Forms
A Phase 1 study testing Cariprazine prolonged release tablet A, Cariprazine prolonged release tablet B and Cariprazine capsule in people with Pharmacokinetic Profile, run by Gedeon Richter Plc. at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Profile
- What is being tested?
- Cariprazine prolonged release tablet A, Cariprazine prolonged release tablet B and Cariprazine capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Feb 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pharmacokinetic Profile
- Being tested
- Cariprazine prolonged release tablet A, Cariprazine prolonged release tablet B, Cariprazine capsule, Cariprazine PR tablet A, Cariprazine PR tablet B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cariprazine prolonged release tablet ADrug
Cariprazine prolonged release tablet A - fasted
Cariprazine prolonged release tablet BDrug
Cariprazine prolonged release tablet B - fasted
Cariprazine capsuleDrug
Cariprazine capsule - fasted
Cariprazine PR tablet ADrug
Cariprazine Prolonged Release tablet A - fed
Cariprazine PR tablet BDrug
Cariprazine Prolonged Release tablet B - fed
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine PR tablet B | Experimental | Cariprazine prolonged release tablet B - fed Receives: Drug: Cariprazine PR tablet B |
| Cariprazine PR tablet A | Experimental | Cariprazine prolonged release tablet A - fed Receives: Drug: Cariprazine PR tablet A |
| Cariprazine capsule | Experimental | Cariprazine capsule - fasted Receives: Drug: Cariprazine capsule |
| Cariprazine prolonged release tablet B | Experimental | Cariprazine prolonged release tablet B - fasted Receives: Drug: Cariprazine prolonged release tablet B |
| Cariprazine prolonged release tablet A | Experimental | Cariprazine prolonged release tablet A - fasted Receives: Drug: Cariprazine prolonged release tablet A |
What is being measured
The primary outcome is the main question the study is designed to answer.
C[max]
Maximum Serum Concentration of the parent drug
Measured: 0-672 hours
AUC
Area Under the Serum Concentration-Time Curve of the parent drug
Measured: 0-672 hours
T[max]
Time to Reach the Maximum Serum Concentration of the parent drug
Measured: 0-672 hours
Secondary outcomes (2)
Other PK parameters of the parent drug
Elimination half-life period (t1/2), Mean Residence Time (MRT), if applicable
Measured: 0-672 hours
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-∞), Elimination half-life period (t1/2) and Mean Residence Time (MRT)
Measured: 0-672 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic ProfileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedeon Richter Plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165098
- Sponsor's protocol ID
- RGH-188-101
- Other IDs
- 2013-004925-99
- Status last verified
- Mar 2016
- First submitted
- 13 Jun 2014
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02165098
- Acronym / sponsor ID
- RGH-188-101
- Conditions
- Pharmacokinetic Profile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Gedeon Richter Plc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cariprazine PR tablet B | Experimental | Drug: Cariprazine PR tablet BCariprazine prolonged release tablet B - fed |
| Cariprazine PR tablet A | Experimental | Drug: Cariprazine PR tablet ACariprazine prolonged release tablet A - fed |
| Cariprazine capsule | Experimental | Drug: Cariprazine capsuleCariprazine capsule - fasted |
| Cariprazine prolonged release tablet B | Experimental | Drug: Cariprazine prolonged release tablet BCariprazine prolonged release tablet B - fasted |
| Cariprazine prolonged release tablet A | Experimental | Drug: Cariprazine prolonged release tablet ACariprazine prolonged release tablet A - fasted |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cariprazine prolonged release tablet ACariprazine prolonged release tablet A - fasted | Drug | Cariprazine prolonged release tablet A |
| Cariprazine prolonged release tablet BCariprazine prolonged release tablet B - fasted | Drug | Cariprazine prolonged release tablet B |
| Cariprazine capsuleCariprazine capsule - fasted | Drug | Cariprazine capsule |
| Cariprazine PR tablet ACariprazine Prolonged Release tablet A - fed | Drug | Cariprazine PR tablet A |
| Cariprazine PR tablet BCariprazine Prolonged Release tablet B - fed | Drug | Cariprazine PR tablet B |
Primary outcome
C[max]
Time frame: 0-672 hours
Maximum Serum Concentration of the parent drug
AUC
Time frame: 0-672 hours
Area Under the Serum Concentration-Time Curve of the parent drug
T[max]
Time frame: 0-672 hours
Time to Reach the Maximum Serum Concentration of the parent drug
2 secondary outcomes
Other PK parameters of the parent drug
Time frame: 0-672 hours
PK parameters of the metabolites, if applicable
Time frame: 0-672 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cariprazine prolonged release tablet A, Cariprazine prolonged release tablet B and Cariprazine capsule in people with Pharmacokinetic Profile, run by Gedeon Richter Plc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C[max] (time frame: 0-672 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.