Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA) (FORZA)
Information provided by (Responsible Party)
First received: August 17, 2009
Last updated: January 7, 2011
Last Verified: January 2011
History of Changes
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.
Drug : fosamprenavir/ritonavir
Drug : olanzapine
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Effect of FOsamprenavir/Ritonavir on the Pharmacokinetics of a Single-dose of the Antipsychotic Agent olanZApine (FORZA)|
Further study details as provided by Radboud University:
Primary Outcome Measures
- olanzapine concentrations [ Time Frame: pharmacokinetic curve after a single dose of olanzapine alone or added to steady state fosamprenavir/ritonavir ]
- adverse events [ Time Frame: entire study ]
|Study Start Date:||November 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
single dose of 15 mg olanzapine after 13 days of fosamprenavir/ritonavir 700mg/100mg BID
16 days 700mg/100mg RTV BID
15 mg olanzapine single dose
single dose olanzapine
Single dose of 10 mg olanzapine
10 mg olanzapine single dose
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.
|Ages Eligible for Study:||18 Years to 55 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
Contacts and LocationsChoosing 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: NCT00977301
Locations Show More
|CRCN, Radboud Universtity Nijmegen Medical Centre|
Sponsors and CollaboratorsRadboud University
|Principal Investigator:||David Burger, PharmD, PhD||Radboud University|
|Responsible Party:||D.M. Burger, PharmD, PhD, Radboud University Nijmegen Medical Centre|
|ClinicalTrials.gov Identifier:||NCT00977301 History of Changes|
|Other Study ID Numbers:||UMCN-AKF 08.04|
|Study First Received:||August 17, 2009|
|Last Updated:||January 7, 2011|
Keywords provided by Radboud University:HIV infection
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.