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

NCT01135680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-06-20

No results posted yet for this study

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).

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01135680 on ClinicalTrials.gov