4-way Crossover QT Evaluation in Healthy Subjects

• Status: Completed
• Trial end date: 2018-08-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if ZTI-01 (fosfomycin for injection), an investigational drug being developed to treat people with complicated urinary tract and kidney infections, has any effect on the electrical activity of the heart.

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

Details

• Lead Sponsor: Nabriva Therapeutics AG; Zavante Therapeutics
• Treatments: Fluoroquinolones; Fosfomycin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• physically and mentally healthy volunteer

• a man or woman, 18 to 55 years of age

• a woman of childbearing potential using birth control / negative pregnancy test or a woman of non-childbearing potential

• males with female partners of childbearing potential agree to use contraception

• body mass index 19.0 to 32.0 kg/m2; weight of at least 60.0 kg at Screening

• willing to complete the required 4 study periods

Exclusion Criteria:

• History or evidence of cerebrovascular or cardiac disease

• Uncontrolled hypertension

• Electrographically significant abnormalities on ECG

• Clinically significant medical history (PI assessment)

• Clinically relevant lab abnormalities (PI assessment)

• Calculated eGFR < 60.0 mL/min/1.73m2 based on CKD-EPI 2009 equation

• Abnormal liver tests

• Positive serology HIV, HBsAg, or Hep C virus

• Hemoglobin, hematocrit, electrolytes below lower limit of normal

• Received any hepatic or renal clearance altering agents within 30 days

• History of allergy or hypersensitivity to drugs with clinically significant reaction

• Unwilling to refrain from strenuous exercise from 7 days prior to admission until discharge

• Uses any prescription drug / OTC, within 7 days prior to admission, or 14 days prior to Admission if the drug is a potential inducer or inhibitor of cP450, or 5 half-lives (if longer), or subject continued use of a prescription drug / OTC medication (except contraceptives)

• Scheduled to have surgical procedure during study

• Acute illness that has resolved in less than 14 days, or has had a major illness, or hospitalization within 1 month

• Unwilling to abstain from ingestion of caffeine or xanthine-containing products 96 hours prior and throughout study

• Unwilling to abstain from alcohol beginning 72 hours prior and throughout study

• History of high alcohol consumption within 6 months

• History of drug abuse (in the previous 3 years) or positive urine drug screen

• Used tobacco-containing products within 6 months or has a positive cotinine

• Consumed grapefruit and/or grapefruit juice within 14 days and throughout study

• Consumed other fruit juices within 72 hours and throughout study

• Consumed cruciferous vegetables or charbroiled meats within 7 days and throughout study

• Donated plasma or blood within 30 days or has a history of blood donation of > 450 mL within 3 months

• Used any investigational drug within 30 days

• Previously received fosfomycin

• Deemed by the Investigator to be inappropriate for this study

• Participated in another clinical study within 30 days (or 5 half-lives)