A Pharmacokinetics and Pharmacodynamics Study Under Fasting and Fed Conditions With Paliperidone Extended-release and Immediate-release Formulations

NCT00796640 | Completed Phase 1

• 1 other identifier: CR004279
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the bioavailability of 2 extended release paliperidone pellet formulations under fasting and fed conditions with a 2 mg paliperidone oral solution under fasting conditions. Additional objectives are to compare the pharmacodynamic effects (postural changes in blood pressure and heart rate), to evaluate the safety and tolerability of each treatment, and to explore the relationship between CYP2D6 genotype and paliperidone exposure.

Conditions

Schizophrenia

Keywords

Schizophrenia; Mood disorders; Antipsychotic drugs; ER Paliperidone

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetics of 2 ER pellet formulations of 2 mg-eq paliperidone in comparison to 2 mg IR paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of the ER pellet formulations

Secondary Outcomes (1)

• To compare the pharmacodynamic effects of all treatments, to evaluate safety and tolerability as well as the relationship between genotypes (CYP2D6 and CYP3A4/5) and paliperidone exposure

Interventions

ER Paliperidone DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (weight \[kg\]/height (m)²) range of 18.0 to 28.0 kg/m², inclusive
• Normotensive with supine (5 minutes) blood pressure between 100 and 140 mmHg systolic, inclusive, and diastolic between 60 and 90 mmHg, inclusive
• Healthy on the basis of a prestudy physical examination, medical history, electrocardiogram, and the laboratory results of blood biochemistry, hematology and urinalysis performed within 21 days before the first dose. If the results of the biochemistry, hematology or urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only if the investigator judges that the deviations are not clinically significant. For liver function tests (alanine transaminase, aspartate transaminase, and bilirubin), the values must be contained within 2 times the upper limits of the normal laboratory reference ranges and for renal function tests, the values must be within the normal laboratory reference ranges
• Women must be postmenopausal for at least 1 year, 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 and at the discretion of the investigator, total abstinence) before entry and throughout the study, as well as have a negative serum pregnancy test at screening. To ensure continued eligibility, women must have a negative urine test before each dose of study drug (Day -1 for each period).

You may not qualify if:

• Known allergy or history of significant hypersensitivity to heparin
• Recent history of alcohol or substance abuse. Test positive for the urine drug screen at screening or the urine drug screen or alcohol breath test at Day -1 for Period 1
• Relevant history of any cardiovascular, respiratory, neuropsychiatric, renal, hepatic, gastrointestinal (including surgeries, and malabsorption problems), endocrine, or immunologic diseases
• A decrease of greater than or equal to 20 mmHg systolic blood pressure 3 minutes after standing, or with symptoms of lightheadedness, dizziness or fainting upon standing at screening
• Positive result for any of the serology tests (hepatitis B, C and HIV)
• Have less than 1 bowel movement on average each day
• History of any cancer, with the exception of basal cell carcinoma
• History of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. (Volunteers must agree to refrain from use throughout the study.)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A pharmacokinetics and pharmacodynamics study under fasting and fed conditions with paliperidone extended-release and immediate-release formulations

MeSH Terms

Conditions

Schizophrenia; Mood Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: September 1, 2003
• Study Completion: November 1, 2003
• Last Updated: June 8, 2011

Record last verified: 2010-03