4-way Crossover QT Evaluation in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Cardiac Repolarization in Healthy Subjects

In brief

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.

Key facts

Study ID

NCT03709927

Run by

Nabriva Therapeutics AG

People needed

41

Starts

2018-01-11

Expected to finish

2018-08-21

Last updated by the study team

2019-03-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pharmaron — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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