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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: Fluvoxamine (Drug); RO4917523 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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

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

Primary outcome: Pharmacokinetics: Area under the concentration time curve

Secondary outcome: Safety: incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Rennes 35042, France
Additional Information

Starting date: July 2012
Last updated: August 17, 2015

Page last updated: August 23, 2015

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