Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
NCT ID: NCT01135680
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2010-05-31
2010-09-30
Brief Summary
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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).
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Detailed Description
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Study acquired from Horizon in 2024.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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Arm 1
Cohort A: 9 mL HPN-100 or placebo
Cohort B: 12 mL HPN-100 placebo
HPN-100
single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
HPN-100 or Placebo
single oral dose of 12 mL HPN-100 given via syringes 3 times daily for 3 days
Arm 2
This study requires 4 periods. In each of the periods you will receive one of the dose groups listed below. At the completion of the study you will have participated in all 4 dose groups. The order in which you participate in each dose group will be randomly assigned.
Dose Group A: 9 mL placebo via oral syringe 3 times daily for 3 days
Dose Group B: single oral dose of 400 mg moxifloxacin on study Day 3
Dose Group C: 6 mL HPN-100 and 3 mL placebo via oral syringe 3 times daily for 3 days
Dose Group D: 9 mL HPN-100 via oral syringe 3 times daily for 3 days
Placebo
single oral (by mouth) dose of 9 mL placebo given via syringes 3 times daily for 3 days
Moxifloxacin
single oral 400-mg dose on study Day 3
HPN-100
single oral dose of 6 mL HPN-100 and 3 mL placebo given via syringes 3 times daily for 3 days
HPN-100
single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
Interventions
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HPN-100
single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
HPN-100 or Placebo
single oral dose of 12 mL HPN-100 given via syringes 3 times daily for 3 days
Placebo
single oral (by mouth) dose of 9 mL placebo given via syringes 3 times daily for 3 days
Moxifloxacin
single oral 400-mg dose on study Day 3
HPN-100
single oral dose of 6 mL HPN-100 and 3 mL placebo given via syringes 3 times daily for 3 days
HPN-100
single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
45 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Covance Clinical Pharmacology, Inc.
Madison, Wisconsin, United States
Countries
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Other Identifiers
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HPN-100-010
Identifier Type: -
Identifier Source: org_study_id
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