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

Acorda Therapeutics

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Other: Placebo; Drug: GGF2; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01944683

GGF2-CV-1007

Details and patient eligibility

About

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

Full description

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

GGF2

Experimental group

Description:

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.

Treatment:

Drug: GGF2

Drug: Midazolam

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Midazolam

Other: Placebo