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

NCT01967979 | Completed Phase 1

• 2 other identifiers: BP289772013-003232-76
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (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)

  up to 5 and 7 days post-dose for cohort 1 and cohort 2, respectively

Secondary Outcomes (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

  up to 6 weeks

Study Arms (2)

Cohort 1 (Itraconazole DDI)

EXPERIMENTAL

Drug: RO5285119; Drug: itraconazole

Cohort 2 (Fluoxetine DDI)

EXPERIMENTAL

Drug: RO5285119; Drug: fluoxetine

Interventions

RO5285119 DRUG

Single dose, alone and after repeated administration of itraconazole or fluoxetine

Cohort 1 (Itraconazole DDI); Cohort 2 (Fluoxetine DDI)

fluoxetine DRUG

Multiple doses

Cohort 2 (Fluoxetine DDI)

itraconazole DRUG

Multiple doses

Cohort 1 (Itraconazole DDI)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Interventions

Fluoxetine; Itraconazole

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)