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Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)

The Effect of FOsamprenavir/Ritonavir on the Pharmacokinetics of a Single-dose of the Antipsychotic Agent olanZApine (FORZA)

NCT00977301•Radboud University Medical Center

View on ClinicalTrials.gov

Summary

The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose of olanzapine will be studied. In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the CYP1A2 and UGT metabolism of olanzapine.

Detailed Description

Psychosis and other mental illnesses are commonly described in patients infected with the human immunodeficiency virus (HIV). New-onset psychosis is estimated to occur in up to 15% of patients infected with HIV while 5 to 7% of patients with HIV-infection suffer from pre-existing mental illnesses including schizophrenia. Olanzapine could be an attractive antipsychotic in HIV/AIDS patients with schizophrenia. Because olanzapine is a substrate for both UGT and CYP1A2, the pharmacokinetics of olanzapine might be influenced by low-dose ritonavir in combination with fosamprenavir. The current study is designed to test this hypothesis. Furthermore, in this study we evaluate the safety of such combination.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject is at least 18 and not older than 55 years at screening.
•Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
•Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
•Subject is in good age-appropriate health condition as established by medical history, physical examination, electro-cardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose. Results of biochemistry, haematology and urinalysis testing should be within the laboratory's reference ranges. If laboratory results are not within the reference ranges, the subject is included on condition that the Investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
•Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.

Exclusion Criteria

•Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
•Positive HIV test.
•Positive hepatitis B or C test.
•Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the first dose) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout the entire conduct of the trial.
•Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
•Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, glaucoma, gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
•Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
•History of or current abuse of drugs, alcohol or solvents.
•Inability to understand the nature and extent of the trial and the procedures required.
•Participation in a drug trial within 60 days prior to the first dose.
+3 more criteria

Locations (1)

CRCN, Radboud Universtity Nijmegen Medical Centre

Nijmegen, Netherlands

Key Dates

Start Date

November 1, 2009

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

November 30, 2020

Enrollment

ESTIMATED participants

Conditions

HIV Infections

Interventions

fosamprenavir/ritonavir

DRUG

olanzapine

DRUG

olanzapine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)

Inclusion Criteria

Exclusion Criteria

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