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

NCT00977301 | Completed Phase 1

• 1 other identifier: UMCN-AKF 08.04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

HIV infection; interaction; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• olanzapine concentrations

  pharmacokinetic curve after a single dose of olanzapine alone or added to steady state fosamprenavir/ritonavir

Secondary Outcomes (1)

• adverse events

  entire study

Study Arms (2)

fosamprenavir/ritonavir/olanzapine

EXPERIMENTAL

single dose of 15 mg olanzapine after 13 days of fosamprenavir/ritonavir 700mg/100mg BID

Drug: fosamprenavir/ritonavir; Drug: olanzapine

single dose olanzapine

ACTIVE COMPARATOR

Single dose of 10 mg olanzapine

Drug: olanzapine

Interventions

fosamprenavir/ritonavir DRUG

16 days 700mg/100mg RTV BID

fosamprenavir/ritonavir/olanzapine

olanzapine DRUG

15 mg olanzapine single dose

fosamprenavir/ritonavir/olanzapine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

CRCN, Radboud Universtity Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Related Publications (1)

• Jacobs BS, Colbers AP, Velthoven-Graafland K, Schouwenberg BJ, Burger DM. Effect of fosamprenavir/ritonavir on the pharmacokinetics of single-dose olanzapine in healthy volunteers. Int J Antimicrob Agents. 2014 Aug;44(2):173-7. doi: 10.1016/j.ijantimicag.2014.03.014. Epub 2014 May 23.

  PMID: 24929949 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

fosamprenavir; Ritonavir; Olanzapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David Burger, PharmD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: September 15, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

NL (1)