The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .
This drug-drug interaction (DDI) study evaluates the potential effect of intravenously administered GGF2 on the elimination kinetics of midazolam.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
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
Safety and tolerability of GGF2 IV infusion in patients with heart failure assessed by review of Treatment Emergent Adverse Events (TEAE)
Time frame: 90 days (± 3 days)
Pharmacokinetic (PK) parameter Area Under the Curve (AUC) of a single dose of midazolam when administered prior to and following a single IV infusion of GGF2 or Placebo
Time frame: Day 1 to Day 7
Change from baseline of 2D-Echocardiogram (2D-ECHO) or ECHO with contrast
Time frame: Visit 1 (day-14 to day-1) and visits 2-5 (day 8 through day 90 ± 3 days)
Change from baseline of the Six-Minute Walk Test (6MWT)
Time frame: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
Change from baseline of metabolic testing measuring maximum capacity of body to transport and use oxygen during incremental exercise (VCO2 and VO2 max)
Time frame: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
Change from baseline of the M.D. Anderson Symptom Inventory (MDASI) score
MDASI is a questionnaire asking patients about the severity of their heart disease symptoms and impact of the symptoms on daily functioning during the past 24 hours. Scale ranges from 0 (sympton has not been present) to 10 (the symptom was as bad as you can imagine it could be).
Time frame: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)
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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