CompletedPhase 1

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

United States98 participantsStarted 2010-05

Plain-language 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).

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 b…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3-day treatment period

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

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

Trial details

NCT IDNCT01135680

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-09

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