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Fluvoxamine

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Fluvoxamine · 1 trial · 1 indication

Phase 1 1
NCT01665404A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy VolunteersHealthy Volunteer
COMPLETED16 Analytics
PHASE1COMPLETED
A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Safety: incidence of adverse events
9 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Dosing Period 1EXPERIMENTAL -
Dosing Period 2EXPERIMENTAL -

Interventions

NameTypeDescription
FluvoxamineDRUGMultiple doses of fluvoxamine
RO4917523DRUGSingle dose of RO4917523
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ch...

Countries:France
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Frequently asked questions about Fluvoxamine

What is Fluvoxamine used for?

Fluvoxamine is a small molecule being studied in a Phase 1 clinical trial in healthy volunteers. The trial is designed to evaluate the effect of Fluvoxamine on the pharmacokinetics of another drug, RO4917523. It is not approved for any indication and remains investigational.

Who makes Fluvoxamine?

Fluvoxamine is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this small molecule drug in healthy volunteer studies.

What phase is Fluvoxamine in?

Fluvoxamine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The current Phase 1 trial is completed, and no active trials are ongoing.

What clinical trials is Fluvoxamine in?

Fluvoxamine has one completed Phase 1 clinical trial, identified as NCT01665404. This study, conducted in France, enrolled 16 healthy volunteers aged 18 years and older to assess the effect of Fluvoxamine on the pharmacokinetics of RO4917523.

Is Fluvoxamine FDA approved?

Fluvoxamine is not FDA approved for the indication being studied. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on healthy volunteers and did not involve a patient population.