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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-07-31

Brief Summary

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

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Detailed Description

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

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

GGF2

Intervention Type DRUG

Midazolam

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Midazolam

Intervention Type DRUG

Interventions

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Placebo

Intervention Type OTHER

GGF2

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No