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An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis

NCT01462318 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2017-03-14

Study results available
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Summary

The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

Midazolam

5 mg

OTHER

Caffeine

200 mg

DRUG

S-warfarin

10 mg

OTHER

Vitamin K

10 mg

DRUG

Omeprazole

40 mg

DRUG

Dextromethorphan

30 mg

BIOLOGICAL

BIIB019 (Daclizumab)

150 mg in 1 ml PFS

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Czechia
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

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 NCT01462318 on ClinicalTrials.gov