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

July 12, 2016 updated by: Acorda Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Medical Center
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Clinical Research Unit
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • New Orleans Center for Clinical Research (NOCCR)
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Midazolam
Drug: GGF2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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
Day 1 to Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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
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).
Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGF2-CV-1007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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