Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)
Information source: Radboud University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: fosamprenavir/ritonavir (Drug); olanzapine (Drug); olanzapine (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
David Burger, PharmD, PhD, Principal Investigator, Affiliation: Radboud University
Overall contact:
David Burger, PhD, PharmD, Phone: ++31 24 3616405, Email: d.burger@akf.umcn.nl
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.
Clinical Details
Official title: The Effect of FOsamprenavir/Ritonavir on the Pharmacokinetics of a Single-dose of the Antipsychotic Agent olanZApine (FORZA)
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: olanzapine concentrations
Secondary outcome: adverse events
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
- Donation of blood within 60 days prior to the first dose.
- Febrile illness within 3 days before the first dose.
- History of narrow-angle glaucoma.
Locations and Contacts
David Burger, PhD, PharmD, Phone: ++31 24 3616405, Email: d.burger@akf.umcn.nl
CRCN, Radboud Universtity Nijmegen Medical Centre, Nijmegen, Netherlands
Additional Information
Starting date: October 2009
Ending date: March 2010
Last updated: September 14, 2009
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