A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Cardiac Effects in Normal Healthy Volunteers

In brief

The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase in the QT interval.

Key facts

Study ID

NCT01514929

Run by

Achaogen, Inc.

People needed

64

Starts

2011-10-01

Expected to finish

2012-03-01

Last updated by the study team

2012-05-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects between 18 and 50 years of age and with a body mass index ≥ 18 to ≤ 33 kg/m2, and weight of ≥ 40 to ≤ 100 kg inclusive.
• Subject is in good health as judged by the investigator based on the laboratory criteria and no clinically significant findings on the medical history or physical examination.
• Females of child-bearing potential (defined as less than one year post-menopause) are eligible for enrollment if they are not breast feeding, they have a negative serum pregnancy test before study entry, and they are using a highly effective method of contraception for at least 3 months before study drug administration, during the study, and for at least 6 months after study completion.
• Subjects who are willing to comply with all study activities and procedures and have provided written informed consent prior to any study procedures and have signed and dated a Health Insurance Portability and Accountability Act (HIPAA) authorization form.

You may not qualify if…

• A history of additional risk factors for TdP.
• Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
• Sustained supine systolic blood pressure >150 mmHg, or <110 mmHg in Part 1 or <100mmHg in Part 2, or a diastolic blood pressure >95 mmHg at screening or baseline.
• A resting pulse rate at rest, taken during screening, of <40 bpm or >100 bpm.
• An abnormal screening ECG indicating a second- or third-degree atrioventricular (AV) block, or one or more of the following: QRS >110 milliseconds (msec), QTcB >470 msec for females or 450 msec for males, PR interval >240 msec, or any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant.
• Uncontrolled hypertension, asthma, unstable diabetes (type I or type II), thyroid disease, seizures, myasthenia gravis, or any other neuromuscular disorder.
• Positive results at screening for hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
• History of central nervous system disorders, epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
• The subject has a history of any cancer, except basal cell or stage 1 squamous cell carcinoma of the skin, which has not been in remission for at least 5 years prior to the first dose of study drug.
• Subjects who have any condition possibly affecting drug absorption.
• History of significant hearing loss or a family history of hearing loss, excluding age related (≥ age 65) hearing loss. A prior diagnosis of sensorineural hearing loss or Ménière's disease.
• Clinically significant illness, including viral syndromes within 3 weeks of dosing.
• The use of concomitant medications that prolong the QT/QTc interval.
• Used prescription medications, over-the-counter (OTC) medications, investigational medications/therapy, vitamins, or nicotine-containing products (eg, cigarettes, cigars, chewing tobacco, snuff, etc.) within 28 days or 5 half-lives, whichever is longer, before dosing of ACHN-490 Injection.
• Used aminoglycosides within 6 months prior to IMP administration.
• Used herbal preparations including St. John's wort, ginseng, kava kava, ginkgo biloba, melatonin, and other nutraceuticals within 28 days prior to IMP administration.
• Consumed caffeine- or xanthine-containing products (eg, tea, coffee, chocolate, cola, etc.), Seville oranges (sour), grapefruit, grapefruit juice, or fish liver oils within 72 hours prior to IMP administration.
• Current participation in a clinical study of an investigational product.
• Consumed more than 28 units of ethanol per week at any time in the 6 months before dosing (1 unit of ethanol is equivalent to 8 ounces of beer, 4 ounces of wine, or 1 ounce of spirits) or history of alcoholism and/or drug/chemical abuse. Also, consumption of any amount of ethanol within 72 hours of ACHN-490 Injection dosing.
• Donated blood or blood components within 60 days prior to receiving study drug.
• Women who are pregnant (or planning to become pregnant within the next 3 months) or currently breastfeeding.
• Previous participation in this or any other ACHN-490 Injection study.
• Known hypersensitivity to aminoglycosides or any component of the ACHN-490 Injection.
• Subjects with poor venous access.
• Unable to understand verbal or written English or any other language for which a certified translation of the informed consent is not available.

Where it is running

• Investigational Site — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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