A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Volunteers

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00892320
First received: November 20, 2008
Last updated: June 6, 2011
Last verified: April 2010
  Purpose

The purposes of this study are to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults and to assess the safety and tolerability.


Condition Intervention Phase
Schizophrenia
Drug: ER OROS paliperidone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Subjects

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults

Secondary Outcome Measures:
  • to evaluate the safety and tolerability of ER OROS paliperidone in healthy Japanese adults

Enrollment: 20
Study Start Date: March 2004
Study Completion Date: May 2004
Detailed Description:

This study was designed as a randomized, open-label, single-center, crossover study to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy Japanese adults. Of the 20 Japanese volunteers who are to be enrolled, at least 6 are to be men and 6 are to be women. All volunteers will receive single doses of 3 mg ER OROS paliperidone with and without a standard Japanese breakfast. There will be a 1-week washout between treatments, for a total treatment duration of approximately 2 weeks. Volunteers are to be randomly assigned to 1 of 2 treatment sequence groups (fed and fasted; fasted and fed). The pharmacokinetics of paliperidone will be assessed for 96 hours after each dosing. Safety and tolerability will be monitored throughout the study. Prior to initiating clinical trials in Japan, a food effect study is required to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in Japanese adults.

3 mg tablets, single oral dose, once under fasting and once under fed conditions

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese volunteers must have been born in Japan of Japanese parents and not lived outside of Japan for more than 5 years
  • Female volunteers must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study, have a negative serum beta-HCG pregnancy test at screening and a negative urine pregnancy test on Day -1
  • Volunteers must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Volunteers must sign informed consent document for pharmacogenomic testing
  • However, participation in the genetic testing component is not mandatory for participation in the remainder of the study
  • Volunteers must have a weight as defined by Body Mass Index or Quetelet Index (weight [kg]/height (m)²) within the range of 18.0 - 25.0, extremes included and must be normotensive with supine (5 min) blood pressure between the range of 100-139 mm Hg systolic and 60-89 mm Hg diastolic
  • Volunteers must be healthy on the basis of a pre-study physical examination, medical history, electrocardiogram, and the results of blood biochemistry and hematology tests and a urinalysis carried out less than 3 weeks before the first dose. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only on condition that the investigator judges that the deviations are not clinically significant. For liver function tests (AST, ALT, bilirubin) the values must be within 2 times the upper limit of the normal reference ranges
  • Volunteers must smoke less than 10 cigarettes per day and agree not to change smoking habits during the study

Exclusion Criteria:

  • Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, psychiatric, or immunologic disorders
  • History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
  • Inability to swallow study medication (volunteers may not chew, divide, dissolve, or crush the study medication)
  • History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse
  • Drug allergy to risperidone, paliperidone or any of its excipients
  • Use of concomitant medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) and hormonal contraceptives. All other medication must have been stopped at least 14 days before the first dose in the study
  • At screening, 2 and 3 minutes after standing, experience a decrease of greater than or equal to 20 mmHg systolic blood pressure, a decrease of greater than or equal to 10 mmHg diastolic blood pressure, or an increase of greater than or equal to 20 beats per minute in heart rate or with symptoms of lightheadedness, dizziness, or fainting upon standing from the supine position
  • Positive serology tests for hepatitis B, C or HIV
  • Female volunteers that are pregnant, nursing, or planning to become pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892320

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00892320     History of Changes
Other Study ID Numbers: CR004936
Study First Received: November 20, 2008
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia, mood stabilizers, antipsychotics
ER OROS paliperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014