A Study to Evaluate the Safety, Tolerability and Plasma PK of a Single Oral Dose of Zoliflodacin … (NCT03404167) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety, Tolerability and Plasma PK of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Volunteers
United States8 participantsStarted 2018-02-02
Plain-language summary
The trial is to evaluate the pharmacokinetics and safety profiles of the single-dose of zoliflodacin in eight healthy male or female subjects ages 18 to 45 years inclusive. All subjects will be dosed in the morning of Day 1 in a staggered fashion with a minimum of several minutes apart. Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g sachets of zoliflodacin) after at least an 8-h fast, which will continue for at least 4 h after dosing. Consumption of water will be permitted during the fasting period. Subjects will be monitored as inpatients in the Clinical Trial Unit (CTU) up to Day 4 and at the Final Visit (Day 8 ± 2). Study duration is approximately 4 weeks with subject participation duration up to 10 days (from dosing to final visit). The primary objective of this study is to evaluate the plasma PK of zoliflodacin after administration of a single 4-g oral dose under fasting conditions.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Informed consent form (ICF) understood and signed before initiating any study procedures
. Healthy male or female, as assessed by the authorized site clinician (listed on FDA Form 1572)
. Willingness to comply with and be available for all protocol procedures including inpatient confinement for about 4 days and availability for follow-up for the duration of the trial
. Aged 18 to 45 years inclusive on the day of study drug dosing
. Body Mass Index (BMI) \> / = 18.5 and \< / = 30 kg/m\^2 and weight \> / = 50 kg (110 lbs.) and \< / = 100 kg (220 lbs.)
. In female subjects of childbearing potential, a negative serum pregnancy test at Screening Visit and on Day -1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Observed Concentration (Cmax) of Zoliflodacin
Timeframe: From Day 1 to Day 4
2
Time of Maximum Observed Concentration (Tmax) of Zoliflodacin
Timeframe: From Day 1 to Day 4
3
Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Zoliflodacin
Timeframe: From Day 1 to Day 4
4
Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin
Timeframe: From Day 1 to Day 4
5
Apparent Volume of Distribution (Vz/F) of Zoliflodacin
Timeframe: From Day 1 to Day 4
6
Apparent Oral Clearance (CL/F) of Zoliflodacin
Timeframe: Day 1 to Day 4
7
Elimination Rate Constant (Ke) of Zoliflodacin
Timeframe: From Day 1 to Day 4
Trial details
NCT IDNCT03404167
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. If female, not pregnant, not breast feeding, and not planning on becoming pregnant during the trial and for 30 days after study participation
. Females of childbearing potential and males agree to use acceptable contraception for the duration of the trial and for 30 days (females) or 90 days (males) after final study visit
8
Terminal Elimination Half-life (t1/2) of Zoliflodacin