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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Treatments: Glycerol; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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