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Completed

NCT Number: NCT01607762

A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aripiprazole

Drug

Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast.

Quetiapine

Drug

Type= exact number, unit= mg, number= 100, form= tablet, route= oral administration. A single oral dose of two 50-mg quetiapine tablets will be administered after an overnight fast.

Olanzapine

Drug

Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast.

Risperidone

Drug

Type= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast.

Paliperidone

Drug

Type= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast.

Primary outcomes

  1. Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood

    Time frame: 16 time points over 408 hours postdose

  2. Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood

    Time frame: 12 time points over 108 hours postdose

  3. Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood

    Time frame: 12 time points over 108 hours postdose

  4. Risperidone concentration in venous and capillary plasma, venous and capillary whole blood

    Time frame: 12 time points over 108 hours postdose

  5. Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood

    Time frame: 12 time points over 108 hours postdose

  6. Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood

    Time frame: 16 time points over 408 hours postdose

  7. 9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood

    Time frame: 12 time points over 108 hours postdose

Secondary outcomes

  1. Incidence of adverse events as a measure of safety and tolerability

    Time frame: Approximately 26 days (Cohorts B, C, D, E), and approximately 39 days (Cohort A)

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 30, 2012
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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