Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin

Completed · Phase 1

Conditions studied: Gonorrhea

In brief

This is a phase I, parallel, open-label, randomized, cross-over, single-center study with zoliflodacin administered as granules for oral suspension with or without food. It is planned to enroll 2 cohorts (Cohorts 1 and 2) of 24 subjects each (48 subjects in total), with the target of achieving data in 20 evaluable subjects per cohort. Single doses of zoliflodacin will be assessed within each cohort in a two period cross-over design. Each subject will receive one of the following regimens per period, depending on cohort, in a sequence according to the randomization schedule (per cohort, subjects will be randomized immediately before dosing in Period 1), separated by a minimum 4 day washout between each period. The actual length of washout period may change pending emerging PK data. Cohort 1: * Regimen A: 3 g zoliflodacin oral suspension; oral administration after an overnight fast * Regimen B: 3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast Cohort 2 * Regimen C: 4 g zoliflodacin oral suspension; oral administration after an overnight fast * Regimen D: 4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast

Key facts

Study ID: NCT03718806
Run by: Drugs for Neglected Diseases
People needed: 48
Starts: 2018-10-03
Expected to finish: 2018-11-12
Last updated by the study team: 2018-12-06

Who can join

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

You may qualify if…

Healthy males or non-pregnant, non-lactating healthy females
Age 18 to 55 years of age
Body mass index of 18.0 to 30.1 kg/m2
Light smokers (less than 5 cigarettes per day) or subjects who are nonsmokers. No smoking (or use of smoking substitute e.g. nicotine patch) is permitted from screening throughout the study
Normal arterial BP and HR or, if abnormal, considered not clinically significant by the PI. These will be measured after resting supine for 10 min
Registered in agreement with the applicable law on biomedical experimentation
Must be willing and able to comply with all study requirements
Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures
Must agree to use an adequate method of contraception
Must, in the opinion of the investigator, be in good health based upon medical history and physical examination (including vital signs)

You may not qualify if…

Subjects who have received of zoliflodacin or any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 3 months
Subjects who are study site employees, or immediate family members of a study site or sponsor employee
Subjects who have previously been enrolled in this study
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
Subjects who have regular daily consumption of ≥5 cigarettes daily, or use more than 3 grams (1/8 ounce) of tobacco
Excessive intake of caffeine (more than 8 cups daily of beverage containing caffeine)
Subjects who have regular daily consumption of more than one liter of xanthine containing beverages
Females of childbearing potential who are pregnant or lactating (female subjects must have a negative serum pregnancy test at screening and admission)
Have poor venous access that limits phlebotomy
Clinically significant abnormal biochemistry, hematology or urinalysis at screening (i.e. aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine and urea must be within normal ranges) as judged by the investigator at screening and admission (laboratory parameters are listed in Appendix 1)
Presence of clinically significant abnormality following review of vital signs, full physical examination and ECG
Positive drugs of abuse test result
History or presence of any clinically significant acute or chronic disease, including known or suspected human immunodeficiency virus (HIV), HBV or HCV infection
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation
History of cardiovascular, renal, hepatic, chronic respiratory or GI disease, or psychiatric disorder, as judged by the investigator
Any clinically important abnormalities in rate, rhythm, conduction or morphology of resting ECG that in the opinion of the PI are clinically significant or may interfere with the interpretation of QTc interval changes
Presence of clinical condition or prior therapy which, in the opinion of the Investigator, made the subject unsuitable for the study
Subjects who have had surgery (e.g. stomach bypass) or medical condition that might affect absorption of study drug taken orally
History of GI ulcer disease, inflammatory bowel disease, indigestion symptoms >3 times a week, or blood in stool in previous 6 months not related to anal trauma
Subjects who have had febrile illness within 1 week before the start of the study
Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
Must not have significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria
History of rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency

Where it is running

Quotient Sciences — Miami, Florida, United States

Full record on ClinicalTrials.gov

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