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Completed

NCT Number: NCT01665404

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluvoxamine

Drug

Multiple doses of fluvoxamine

RO4917523

Drug

Single dose of RO4917523

Primary outcomes

  1. Pharmacokinetics: Area under the concentration time curve

    Time frame: Period 1: Pre-dose and up to Day 14, Period 2: pre-dose and up to Day 26

Secondary outcomes

  1. Safety: incidence of adverse events

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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