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
Completed · Phase 1 · Has a placebo group
Conditions studied: Heart Failure
In brief
The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .
Key facts
- Study ID
- NCT01944683
- Run by
- Acorda Therapeutics
- People needed
- 22
- Starts
- 2013-09-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2016-07-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- UCSD Medical Center — La Jolla, California, United States
- Orange County Research Center — Tustin, California, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- Tulane University School of Medicine — New Orleans, Louisiana, United States
- Duke Clinical Research Unit — Durham, North Carolina, United States
- New Orleans Center for Clinical Research (NOCCR) — Knoxville, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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