Status:
COMPLETED
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Lead Sponsor:
Amgen
Conditions:
Drug Toxicity
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 le...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01135680
Start Date
May 1 2010
End Date
September 1 2010
Last Update
June 20 2024
Active Locations (1)
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1
Covance Clinical Pharmacology, Inc.
Madison, Wisconsin, United States, 53704