Trial record 11 of 33 for:    Acorda

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Acorda Therapeutics
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01944683
First received: September 11, 2013
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Heart Failure
Other: Placebo
Drug: GGF2
Drug: Midazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

    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).



Estimated Enrollment: 28
Study Start Date: September 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944683

Locations
United States, California
UCSD Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Melanee Schimmel    858-657-5374    mschimmel@ucsd.edu   
Principal Investigator: Barry H Greenberg, MD         
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact: Susan Bague    714-263-7323    susan.bague@ocresearchcenter.com   
Principal Investigator: Joel M Neutel, MD         
United States, Florida
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact: Rachel Starnes, BS    904-730-0101    rstarnes@encoredocs.com   
Principal Investigator: Michael J Koren, MD         
United States, Louisiana
Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Roberta McDuffie    504-988-0299    rmcduffi@tulane.edu   
Principal Investigator: Patrice Delafontaine, MD         
United States, North Carolina
Duke Clinical Research Unit Recruiting
Durham, North Carolina, United States, 27710
Contact: Kim Lynch    919-684-4888    kim.lynch@duke.edu   
Principal Investigator: Robert J Noveck, MD, PhD         
United States, Tennessee
New Orleans Center for Clinical Research (NOCCR) Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Colleen Hayzen, RN    865-305-9100 ext 6    chayzen@noccr.com   
Principal Investigator: William B Smith, MD         
Kore Cardiovascular Research Institute Recruiting
Lexington, Tennessee, United States, 38351
Contact: Donna Manns    731-512-0104    dmanns@koreresearch.com   
Principal Investigator: Elie Hage-Korban, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Tami Neal    615-936-1518    tami.neal@vanderbilt.edu   
Principal Investigator: Daniel J Lenihan, MD         
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Enrique Carrazana, MD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01944683     History of Changes
Other Study ID Numbers: GGF2-CV-1007
Study First Received: September 11, 2013
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014