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
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Lead
Acorda Therapeutics
This drug-drug interaction (DDI) study evaluates the potential effect of intravenously administered GGF2 on the elimination kinetics of midazolam.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
If female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
If male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. Must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
Stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
All cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to Day 1
You may not be if
Any previous exposure to GGF2 or other neuregulins
Initiation or change of a prescription medication within the 2 weeks prior to Day 1, and/or concomitant medication regimen is expected to change during the course of the study
Known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of GGF2 diluent
Known specific hepatic disease; total bilirubin \>2 mg/dL, AST \> 100 IU
History of hepatic impairment (hepatitis B and C)
Type I Diabetes
Documented stroke or transient ischemic attack (TIA) within 2 months of study enrollment
Clareo Health | 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
