Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100

PHASE1CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Drug Toxicity
Interventions
DRUG

HPN-100

single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days

DRUG

HPN-100 or Placebo

single oral dose of 12 mL HPN-100 given via syringes 3 times daily for 3 days

DRUG

Placebo

single oral (by mouth) dose of 9 mL placebo given via syringes 3 times daily for 3 days

DRUG

Moxifloxacin

single oral 400-mg dose on study Day 3

DRUG

HPN-100

single oral dose of 6 mL HPN-100 and 3 mL placebo given via syringes 3 times daily for 3 days

DRUG

HPN-100

single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days

Trial Locations (1)

53704

Covance Clinical Pharmacology, Inc., Madison

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY