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A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01967979
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single-center, open-label, one-sequence, 2-period, within-subject study in 2 cohorts will evaluate the effects of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers. In Cohort 1, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, itraconazole on Days 1-8 of Period 2 with coadministration of RO5285119 on Day 4. In Cohort 2, subjects will receive a single dose of RO5285119 on Day 1 (Period 1) and, after a wash-out period of 14 days, fluoxetine on Days 1-12 of Period 2 with coadministration of RO5285119 on Day 6.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5285119 Drug: fluoxetine Drug: itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Single-Center, Open-Label, One-Sequence, 2-Period, Within-Subject Study in 2 Cohorts to Investigate the Effect of Multiple Doses of Itraconazole (Cohort 1) and Fluoxetine (Cohort 2) on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects
Study Start Date : October 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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Arm Intervention/treatment
Experimental: Cohort 1 (Itraconazole DDI) Drug: RO5285119
Single dose, alone and after repeated administration of itraconazole or fluoxetine

Drug: itraconazole
Multiple doses

Experimental: Cohort 2 (Fluoxetine DDI) Drug: RO5285119
Single dose, alone and after repeated administration of itraconazole or fluoxetine

Drug: fluoxetine
Multiple doses




Primary Outcome Measures :
  1. Effect of multiple doses of itraconazole and fluoxetine on the pharmacokinetics of a single dose of RO5285119 in healthy volunteers: Maximum concentration (Cmax) / Area under the concentration-time curve (AUC) [ Time Frame: up to 5 and 7 days post-dose for cohort 1 and cohort 2, respectively ]

Secondary Outcome Measures :
  1. Safety and tolerability of a single dose of RO5285119 administered in combination with itraconazole (cohort 1) and fluoxetine (cohort 2): Incidence of adverse events [ Time Frame: up to 6 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects, 18 to 55 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination
  • Body mass index (BMI) between 18 to 30 kg/m2 inclusive
  • Women must be postmenopausal (for at least 12 months of amenorrhea confirmed by FSH, or for at least 24 months if on hormone replacement therapy) or surgically sterile (absence of ovaries and/or uterus)
  • For men with a female partner of child-bearing potential: agreement to use a barrier method of contraception during the treatment period and for at least 3 months after the last dose of study drug

Exclusion Criteria:

  • Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
  • Positive for hepatitis B, hepatitis C , or HIV infection
  • Participation in an investigational drug or device study within 90 days prior to first dosing
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Hypersensitivity to itraconazole, to any of the other ingredients, or to any other triazole antifungal, or any other known contraindications to itraconazole as stated in the SmPC
  • Hypersensitivity to fluoxetine or to any of the other ingredients, or any other known contraindications to fluoxetine as stated in the SmPC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967979


Locations
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Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01967979     History of Changes
Other Study ID Numbers: BP28977
2013-003232-76 ( EudraCT Number )
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Fluoxetine
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors