Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults
NCT01659944 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2015-03-23
Summary
The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in healthy adults.
The secondary objective is to assess the safety and tolerability of a single oral dose of metoprolol 50 mg when administered alone and in combination with repeated oral doses of eliglustat 150 mg BID in healthy adults.
Conditions
- Healthy
Interventions
- DRUG
-
Eliglustat
Capsules for oral administration
- DRUG
-
Metoprolol
Tablets for oral administration
Sponsors & Collaborators
-
Genzyme, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Genzyme, a Sanofi Company
Study Design
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2012-06-30
- Completion
- 2012-07-31
Countries
- United States
Study Locations
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