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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acorda Therapeutics
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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