Drug Toxicity Clinical Trial
Official 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
NCT number | NCT01135680 |
Other study ID # | HPN-100-010 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | September 2010 |
Verified date | June 2024 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 98 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Covance Clinical Pharmacology, Inc. | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability as measured by the rate and severity of adverse events in each treatment group. | 3-day treatment period | ||
Primary | Changes from baseline QTcI as a measure of effects of study-state HPN-100 metabolites: PBA, PAA, and PAGN | 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments | ||
Secondary | Correlate time-matched ECG waveform changes to steady-state levels of HPN-100 by using QTcB and QTcF formulas to assess ECG morphologic changes. | 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments | ||
Secondary | 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 | 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments | ||
Secondary | 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. | 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments | ||
Secondary | Number and severity of adverse events in each treatment group. | 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments |
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