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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 health 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 (QTcl). Study acquired from Horizon in 2024.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
United States Covance Clinical Pharmacology, Inc. Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

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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