A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Fluvoxamine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665404
• Other study ID #: BP28250
• Secondary ID: 2012-000772-42
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2012
• Last updated: November 1, 2016
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - French Health Products Safety Agency
• Study type: Interventional

Clinical Trial Summary

This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a cross-over design. The anticipated time on study treatment is 40 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers, 18-65 years of age inclusive

• Non-smokers

• Body mass index (BMI) between 18 and 30 mg/m2 inclusive

• Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria:

• Evidence of any active or chronic disease

• History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer History or presence of clinically significant psychiatric condition

• Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Fluvoxamine
Multiple doses of fluvoxamine
• RO4917523
Single dose of RO4917523

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration time curve		Period 1: Pre-dose and up to Day 14, Period 2: pre-dose and up to Day 26	No
Secondary	Safety: incidence of adverse events		9 weeks	No