Skip to main content
OpenTrials
Completed

NCT Number: NCT01135680

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Drug Toxicity Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Pharmacology, Inc.

Madison, Wisconsin, 53704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be in good health
  • Negative hepatitis panel and negative HIV antibody screens
  • Females must be non-pregnant, non-lactating, and either postmenopausal or agree to to use adequate contraceptive methods throughout the study
  • Males must either be sterile or willing to use adequate contraceptive methods throughout the study
  • Willing and able to comply with all trial requirements
  • Able to comprehend and willing to sign an Informed Consent Form (ICF)

Exclusion criteria

  • History or clinical manifestations of significant allergic, metabolic, hepatic, renal, endocrine, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders
  • History of hypersensitivity or allergies to any drug compound
  • History of stomach or intestinal surgery or resection
  • History or presence of an abnormal ECG
  • History of alcoholism or drug addiction within 1 year
  • Use of any tobacco-containing or nicotine-containing products within 3 months
  • Participated in any other clinical trial of an investigational drug (or a medical device) within 30 days
  • Use of any prescription medications/products other than contraceptives within 14 days
  • Use of any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days
  • Test positive for drug(s) of abuse, ethanol, or cotinine
  • Have donated blood or blood components within 30 days
  • Have received blood products within 2 months
  • Have a history of unexplained syncope
  • Have a family history of unexplained sudden death

Treatment and study plan

HPN-100

Drug

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

HPN-100 or Placebo

Drug

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

Placebo

Drug

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

moxifloxacin

Drug

single oral 400-mg dose on study Day 3

Primary outcomes

  1. Safety and tolerability as measured by the rate and severity of adverse events in each treatment group.

    Time frame: 3-day treatment period

  2. Changes from baseline QTcI as a measure of effects of study-state HPN-100 metabolites: PBA, PAA, and PAGN

    Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments

Secondary outcomes

  1. Correlate time-matched ECG waveform changes to steady-state levels of HPN-100 by using QTcB and QTcF formulas to assess ECG morphologic changes.

    Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments

  2. Correlate time-matched QTcI change from baseline and serum levels of PBA, PAA, and PAGN drawn on Day 1, Day 2, Day 3, and Day 4

    Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments

  3. Gender differences in metabolism of HPN-100 as measured by time-matched serum levels of HTN-100, PBA, PAA, and PAGN via samples drawn on Day 1, Day 2, Day 3, and Day 4.

    Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments

  4. Number and severity of adverse events in each treatment group.

    Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2010
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.