A Double-Blind Pharmacokinetic Interaction Study Evaluati... | NCT01944683 | Trialant

A Double-Blind Pharmacokinetic Interaction Study Evaluati... | NCT01944683 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GGF2	Experimental	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	Placebo Comparator	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of GGF2 IV infusion in patients with heart failure assessed by review of Treatment Emergent Adverse Events (TEAE)		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		Day 1 to Day 7

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline of 2D-Echocardiogram (2D-ECHO) or ECHO with contrast		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)		Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days)

Contacts/Locations Module