NCT01135680

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

Double-Blind Randomized Placebo-Control Trial to Evaluate Electrocardiogram Effects of HPN-100 as Defined by Clinical and Supratherapeutic Dose in Healthy Men and Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Arm 1: Primary Objective: • To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: • To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid \[PBA\], phenylacetic acid \[PAA\], and phenylacetylglutamine \[PAGN\]) on 12-lead electrocardiogram (ECG) parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate (HR) based on an individual correction method (QTcI).

Detailed description

Assess the effects of steady-state levels of HPN-100 metabolites (4-phenylbutryic acid (PBA), phenylacetic acid (PAA), and phenylacetylglutamine (PAGN) on 12-lead electrocardiogram (ECG) parameters in health male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate(HR) based on an individual correction method (QTcl). Study acquired from Horizon in 2024.

Conditions

• Drug Toxicity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-06-03
• Last updated: 2024-06-20

Locations

1 site across 1 country: United States