Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01944683
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

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

Condition or disease Intervention/treatment Phase
Heart Failure Other: Placebo Drug: GGF2 Drug: Midazolam Phase 1

Detailed Description:
This drug-drug interaction (DDI) study evaluates the potential effect of intravenously administered GGF2 on the elimination kinetics of midazolam.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1b Study of Pharmacokinetic Interaction, Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
Study Start Date : September 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: GGF2

Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.

Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively.

Drug: GGF2
Drug: Midazolam
Placebo Comparator: Placebo

Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.

Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively.

Other: Placebo
Drug: Midazolam



Primary Outcome Measures :
  1. 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) ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Change from baseline of the M.D. Anderson Symptom Inventory (MDASI) score [ Time Frame: Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days) ]

    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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944683


Locations
Layout table for location information
United States, California
UCSD Medical Center
La Jolla, California, United States, 92037
Orange County Research Center
Tustin, California, United States, 92780
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
United States, Tennessee
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, United States, 37920
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Virginia
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Layout table for investigator information
Study Director: Andrew Eisen, MD Acorda Therapeutics

Layout table for additonal information
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01944683     History of Changes
Other Study ID Numbers: GGF2-CV-1007
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action