GonorrheaPhase 1NCT03718806
Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin
A Phase 1 study testing Zoliflodacin and high calorie, high fat breakfast in people with Gonorrhea, run by Drugs for Neglected Diseases at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gonorrhea
- What is being tested?
- Zoliflodacin and high calorie, high fat breakfast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2018to 12 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
- History of major surgical procedure or have donated of blood within 12 weeks prior to first dose of study medication or plasma within 7 days prior to first dose of study medication
- Must not donate blood from clinic admission, throughout the study duration, and for at least 30 days following last dose of study medication
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug, including antacid drug, (other than 4 g per day acetaminophen, hormone replacement therapy, hormonal contraception) in the 28 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor
- Use of dietary supplements or herbal remedies (such as St John's Wort), or grapefruit products known to interfere with the CYP3A4 and/or P-gp metabolic pathways during the 14 days before the first dose of trial medication
- Individuals who have been vaccinated within 4 to 6 weeks before dose administration of the IMP or planned to be vaccinated up to 4 to 6 weeks after dose administration of the IMP
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Study to Investigate Pharmacokinetics, Effect of Food and Safety of a New Immediate-Release Formulation of Zoliflodacin in Healthy Subjects
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.
Read more
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
- Conditions
- Gonorrhea
- Being tested
- Zoliflodacin, high calorie, high fat breakfast
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoliflodacinDrug
oral suspension; oral administration
high calorie, high fat breakfastOther
fasted/fed conditions
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | 3 g zoliflodacin oral suspension; oral administration after an overnight fast Receives: Drug: Zoliflodacin |
| Regimen B | Experimental | 3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast Receives: Drug: Zoliflodacin; Other: high calorie, high fat breakfast |
| Regimen C | Experimental | 4 g zoliflodacin oral suspension; oral administration after an overnight fast Receives: Drug: Zoliflodacin |
| Regimen D | Experimental | 4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast Receives: Drug: Zoliflodacin; Other: high calorie, high fat breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter of zoliflodacin : Cmax
the maximum observed concentration of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Measured: Day 3
PK parameter of zoliflodacin : Tmax
Tmax (the elapsed time from dosing at which Cmax was apparent) of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Measured: Day 3
PK parameter of zoliflodacin : AUC
Area Under the Curve of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Measured: Day 3
PK parameter of zoliflodacin : T1/2
the apparent elimination half-life of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Measured: Day 3
Secondary outcomes (4)
safety and tolerability of zoliflodacin
safety and tolerability of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Measured: end of study
relative bioavailability (Cmax) of zoliflodacin in the fed and fasted states
To determine the maximum observed concentration (Cmax) of zoliflodacin in the fed and fasted states
Measured: Day 3
relative bioavailability (AUC) of zoliflodacin in the fed and fasted states
To determine the Area Under the Curve (AUC) of zoliflodacin in the fed and fasted states
Measured: Day 3
zoliflodacin effect on QT intervals
To collect 12-lead Holter recordings to assess QTcP, QTcF, QT intervals corrected with Bazett's formula
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start3 Oct 2018
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- It is planned to enroll 2 cohorts of 24 subjects each. Single doses of zoliflodacin (3 g and 4 g) will be assessed within each cohort in a two period cross-over design. 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 There will be a minimum washout of 4 days between each period.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Juan Perez-Morales, MD, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718806
- Sponsor's protocol ID
- STI_ZOLI002
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Study to Investigate Pharmacokinetics, Effect of Food and Safety of a New Immediate-Release Formulation of Zoliflodacin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03718806
- Acronym / sponsor ID
- STI_ZOLI002
- Conditions
- Gonorrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Quotient Sciences
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- It is planned to enroll 2 cohorts of 24 subjects each. Single doses of zoliflodacin (3 g and 4 g) will be assessed within each cohort in a two period cross-over design. 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 There will be a minimum washout of 4 days between each period.
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: Zoliflodacin3 g zoliflodacin oral suspension; oral administration after an overnight fast |
| Regimen B | Experimental | Drug: Zoliflodacin, Other: high calorie, high fat breakfast3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast |
| Regimen C | Experimental | Drug: Zoliflodacin4 g zoliflodacin oral suspension; oral administration after an overnight fast |
| Regimen D | Experimental | Drug: Zoliflodacin, Other: high calorie, high fat breakfast4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (31 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoliflodacinoral suspension; oral administration | Drug | Regimen A, Regimen B, Regimen C, Regimen D |
| high calorie, high fat breakfastfasted/fed conditions | Other | Regimen B, Regimen D |
Primary outcome
PK parameter of zoliflodacin : Cmax
Time frame: Day 3
the maximum observed concentration of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
PK parameter of zoliflodacin : Tmax
Time frame: Day 3
Tmax (the elapsed time from dosing at which Cmax was apparent) of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
PK parameter of zoliflodacin : AUC
Time frame: Day 3
Area Under the Curve of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
PK parameter of zoliflodacin : T1/2
Time frame: Day 3
the apparent elimination half-life of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
4 secondary outcomes
safety and tolerability of zoliflodacin
Time frame: end of study
relative bioavailability (Cmax) of zoliflodacin in the fed and fasted states
Time frame: Day 3
relative bioavailability (AUC) of zoliflodacin in the fed and fasted states
Time frame: Day 3
zoliflodacin effect on QT intervals
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Perez-Morales, MD principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zoliflodacin and high calorie, high fat breakfast in people with Gonorrhea, run by Drugs for Neglected Diseases at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameter of zoliflodacin : Cmax (time frame: Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.