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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO4917523; Drug: Fluvoxamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01665404

2012-000772-42 (EudraCT Number)

BP28250

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 2 patient groups

Dosing Period 1

Experimental group

Treatment:

Drug: RO4917523

Dosing Period 2

Experimental group

Treatment:

Drug: RO4917523

Drug: Fluvoxamine