A Drug Interaction Study of Valproic Acid and Single-dose Paliperidone Extended-Release (ER) in Healthy Men

NCT01060228 | Completed Phase 1

• 2 other identifiers: CR015802R076477BIM1003
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of valproic acid (VPA) on the pharmacokinetics (blood levels) of a single oral dose of an extended-release formulation of paliperidone in healthy male volunteers.

Conditions

Schizophrenia; Epilepsy

Keywords

Paliperidone ER; INVEGA; Divalproex sodium; Depakote ER; Pharmacokinetics; Valproic Acid; Human Experimentation

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetics of a single dose of orally administered paliperidone ER before and during the administration of VPA at steady-state

  Blood samples taken within 2 hours before dosing on Day 1, and during 96 hours after dosing on Day 15 with paliperidone ER

Secondary Outcomes (2)

• To determine the effect of a single dose of paliperidone ER on steady-state VPA plasma concentrations

  Predose on Days 12 to 16, and 19

• To evaluate safety and tolerability of the 12-mg tablet of paliperidone ER administered with and without divalproex sodium ER

  Day -1 through the last study assessment on Day 19.

Study Arms (2)

001

OTHER

paliperidone ER 1 tablet of 500 mg once daily on Day 1 and Day 15

Drug: paliperidone ER

002

OTHER

divalproex sodium ER 2 tablets of 500 mg once daily from Days 5 through 18

Drug: divalproex sodium ER

Interventions

paliperidone ER DRUG

1 tablet of 500 mg once daily on Day 1 and Day 15

001

divalproex sodium ER DRUG

2 tablets of 500 mg once daily from Days 5 through 18

002

Eligibility Criteria

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

You may qualify if:

• Signed informed consent obtained indicating an understanding of the purpose of and procedures required for the study and willingness to participate in the study
• Agree to use an adequate contraception method as deemed appropriate by the study physician (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
• Have a body mass index (BMI, weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
• Have a systolic blood pressure between 90 and 140 mm Hg and a diastolic blood pressure between 50 and 90 mm Hg
• Habitually smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to) drug or alcohol abuse within the past 5 years, cancer with exception of basal cell carcinoma, epilepsy, suspected urea cycle disorder, any severe pre-existing gastrointestinal narrowing or malabsorption problems, cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the study physician considers should exclude the healthy volunteer or that could interfere with the interpretation of the study results
• Known allergy or intolerance to study drugs including paliperidone, valproic acid (VPA), sodium valproate, or divalproex sodium or any of the excipients (inactive substances) of the drugs (such as lactose)
• Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study or within 1 month after the completion of the study
• Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drugs)
• Preplanned surgery or procedures that would interfere with the conduct of the study

Sponsors & Collaborators

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

Related Links

• An Open-Label, Drug-Drug Interaction Study between Steady-State Valproic Acid and Single-Dose Paliperidone Extended-Release in Healthy Men

MeSH Terms

Conditions

Schizophrenia; Epilepsy

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

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: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 2, 2010
• Study Start: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 24, 2012

Record last verified: 2012-12