Clinical trial NCT01607762: A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics
Official title: Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Antipsychotics
Aripiprazole
Paliperidone
Risperidone
Quetiapine
Olanzapine
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-05-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare capillary (the smallest of a body's blood vessels) and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single oral, immediate-release dose to healthy participants.

Detailed description: This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be treated at the same time), single-center study. Participants will be randomly assigned to 1 of 5 cohorts (groups) defined by the antipsychotic drug (aripiprazole, quetiapine, olanzapine, risperidone or paliperidone). Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Participants will enter the investigational site in the morning of Day -1 and stay until the morning of Day 2. Participants will return to the study site for subsequent assessments as per study's schedule. The total study length for a participant is approximately 26 days, except for participants receiving aripiprazole for whom the total study length is approximately 39 days.

Eligibility criteria: Inclusion Criteria:

* Body mass index (weight \[kg\]/height2 \[m\]2) between 17 and 35 kg/m2 (inclusive), and body weight not less than 50 kg
* If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
* If a woman, must have negative pregnancy test at screening
* If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria:

* History of or current clinically significant medical illness or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for laboratorial tests
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen), oral contraceptives and hormonal replacement therapy, within 14 days before the study drug administration is scheduled
* Positive test for alcohol or drugs of abuse at screening
* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)

Primary outcomes:
measure: Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood
timeFrame: 16 time points over 408 hours postdose
measure: Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood
timeFrame: 12 time points over 108 hours postdose
measure: Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood
timeFrame: 12 time points over 108 hours postdose
measure: Risperidone concentration in venous and capillary plasma, venous and capillary whole blood
timeFrame: 12 time points over 108 hours postdose
measure: Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood
timeFrame: 12 time points over 108 hours postdose
measure: Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood
timeFrame: 16 time points over 408 hours postdose
measure: 9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood
timeFrame: 12 time points over 108 hours postdose
Secondary outcomes:
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: Approximately 26 days (Cohorts B, C, D, E), and approximately 39 days (Cohort A)
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: