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Sarilumab Effect on the Pharmacokinetics of Simvastatin

NCT02017639 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-04-07

No results posted yet for this study

Summary

Primary Objective:

To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis

Secondary Objective:

To describe the safety and efficacy (exploratory) of sarilumab

Conditions

Interventions

DRUG

sarilumab SAR153191 (REGN88)

Pharmaceutical form:Prefilled syringe of sarilumab solution Route of administration: Subcutaneous injection

DRUG

simvastatin

Pharmaceutical form:Film-coated 20 mg Tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States
  • Moldova
  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017639 on ClinicalTrials.gov