A Double-Blind Pharmacokinetic Interaction Study Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
NCT01944683 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2016-07-13
Summary
The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .
Conditions
Interventions
- OTHER
-
Placebo
- DRUG
-
GGF2
- DRUG
-
Midazolam
Sponsors & Collaborators
-
Acorda Therapeutics
lead INDUSTRY
Principal Investigators
-
Andrew Eisen, MD · Acorda Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2016-05-31
- Completion
- 2016-07-31
Countries
- United States
Study Locations
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