Healthy VolunteersPhase 1NCT05271799
A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants
A Phase 1 study testing Gepotidacin in people with Healthy Volunteers, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is a randomized, open-label, two periods, cross-over pharmacokinetic, safety, tolerability and relative bioavailability of gepotidacin in healthy adult male and female participants of aged 18 to 50 years. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Gepotidacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 22 Apr 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 50 years of age, inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results. A participant with a clinical abnormality or laboratory parameters outside the reference range may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight more than or equal to (>=) 50.0 kilograms (kg) (110 pound) for males and >=45 kg (99 pound) for females and body mass index within the range 18.5 to 32.0 kilogram per square meters (kg/m^2) (inclusive).
- Male or Female: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period until completion of the follow-up visit: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below: Agree to use a male condom with female partner and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is not a WOCBP OR Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of less than (<) 1 percent (%), for at least 30 days prior to dosing until completion of the follow up visit. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Who cannot join
- History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Abnormal blood pressure as determined by the investigator or designee
- Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention, or any other condition that may place the participant at risk, in the opinion of the investigator.
- Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening.
- Use of any systemic antibiotic within 30 days of screening.
- Within 2 months before screening, either a confirmed history of Clostridium difficile diarrhea infection or a past positive of Clostridium difficile toxin test.
Show all 25Show fewer
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert syndrome or asymptomatic gallstones).
- History of drug and/or alcohol abuse within 6 months before screening, as determined by the investigator, or has a positive drug screen at screening or upon admission to the clinic.
- History of sensitivity/hypersensitivity to any of the study drugs, components thereof, or a history of drug or other allergy that, in the opinion of the investigator or the GlaxoSmithKline medical monitor contraindicates their participation.
- History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic uses heparin to maintain intravenous cannula patency).
- Impaired sense of taste or smell, in the opinion of the investigator.
- Participants must abstain from taking prescription or non-prescription drugs (except for hormonal contraceptives and/or acetaminophen [up to 2 grams per day]), vitamins, and dietary or herbal supplements, within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Participants must abstain from taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor within 7 days or 5 half-lives (whichever is longer).
- Previous exposure to gepotidacin within 12 months prior to starting study intervention
- Participant has participated in a clinical trial and has received an investigational product prior to gepotidacin administration within 30 days, 5 half-lives, or twice the duration of the biological effect of investigational product (whichever is longer).
- Participant has participated in a clinical trial with frequent blood sampling and/or sampling blood volumes that in total may reached an extracted blood volume above 7 milliliter per kilogram (mL/kg) (i.e., approximately 500 milliliter (mL) for a 70 kg participant) within the previous 56 days prior to informed consent.
- Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
- Alanine aminotransferase (ALT) more than (>)1.5 * upper limit of normal (ULN) at screening or check-in.
- Bilirubin >1.5 * ULN (isolated bilirubin >1.5 * ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening or check-in.
- History of any kidney disease or current or chronic history of impaired renal function as indicated by an estimated creatinine clearance <60 milliliter per minute (mL/min).
- A positive test for human immunodeficiency virus antibody.
- History of regular alcohol consumption within 6 months of screening defined as an average weekly intake of >21 units (or an average daily intake of >3 units) for males or an average weekly intake of >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 270 mL of full-strength beer, 470 mL of light beer, 30 mL of spirits, or 100 mL of wine.
- Urinary cotinine level indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months of screening.
- Clinically significant abnormal findings in serum chemistry, hematology, or urinalysis results obtained at screening or check-in (Day-1).
- Baseline QTcF of >450 milliseconds (msec) at screening or check-in (Day-1).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Study to Compare Gepotidacin Powder for Oral Suspension With the Adult Tablet Formulation in Healthy Male and Female Participants Aged 18 to 50 Years
This study is a randomized, open-label, two periods, cross-over pharmacokinetic, safety, tolerability and relative bioavailability of gepotidacin in healthy adult male and female participants of aged 18 to 50 years.
- Conditions
- Healthy Volunteers
- Being tested
- Gepotidacin
- Keywords
- Gepotidacin, Relative Bioavailability, Healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GepotidacinDrug
Gepotidacin will be administered
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving gepotidacin powder for oral suspension followed by tablet | Experimental | Not described Receives: Drug: Gepotidacin |
| Participants receiving gepotidacin tablet followed by powder for oral suspension | Experimental | Not described Receives: Drug: Gepotidacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periods 1 and 2: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Maximum observed plasma concentration (Cmax) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Secondary outcomes (12)
Periods 1 and 2: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 14 days
Periods 1 and 2: Maximum change from Baseline in QT interval corrected with Fridericia's method (QTcF)
Measured: Baseline and up to 14 days
Periods 1 and 2: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin.
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Absorption lag time (Tlag) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Terminal phase half-life (t1/2) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Apparent volume of distribution (Vz/F) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Relative bioavailability (Frel) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Apparent oral clearance (CL/F) of gepotidacin
Blood samples will be collected for the concentrations of gepotidacin
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: AUC from time zero to 24 hours (AUC[0-24]) of gepotidacin
Urine samples will be collected for the concentrations of gepotidacin.
Measured: Up to 24 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Total unchanged drug (Ae total) of gepotidacin
Urine samples will be collected for the concentrations of gepotidacin.
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin
Urine samples will be collected for the concentrations of gepotidacin.
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Renal clearance of drug (CLr) of gepotidacin
Urine samples will be collected for the concentrations of gepotidacin.
Measured: Up to 48 hours post dose in each period (each period is 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Mar 2022
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- This is a two periods, crossover study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271799
- Sponsor's protocol ID
- 207729
- Status last verified
- Jan 2023
- First submitted
- 28 Feb 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Study to Compare Gepotidacin Powder for Oral Suspension With the Adult Tablet Formulation in Healthy Male and Female Participants Aged 18 to 50 Years
- ClinicalTrials.gov ID
- NCT05271799
- Acronym / sponsor ID
- 207729
- Conditions
- Healthy Volunteers
- Keywords
- Gepotidacin, Relative Bioavailability, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 9 Mar 2022 (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 study is a randomized, open-label, two periods, cross-over pharmacokinetic, safety, tolerability and relative bioavailability of gepotidacin in healthy adult male and female participants of aged 18 to 50 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two periods, crossover study
| Arm | Type | Receives |
|---|---|---|
| Participants receiving gepotidacin powder for oral suspension followed by tablet | Experimental | Drug: Gepotidacin |
| Participants receiving gepotidacin tablet followed by powder for oral suspension | Experimental | Drug: Gepotidacin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be 18 to 50 years of age, inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results. A participant with a clinical abnormality or laboratory parameters outside the reference range may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight more than or equal to (>=) 50.0 kilograms (kg) (110 pound) for males and >=45 kg (99 pound) for females and body mass index within the range 18.5 to 32.0 kilogram per square meters (kg/m^2) (inclusive).
- Male or Female: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a. Male participants: Male participants are eligible to participate if they agree to the following during the study intervention period until completion of the follow-up visit: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below: Agree to use a male condom with female partner and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is not a WOCBP OR Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of less than (<) 1 percent (%), for at least 30 days prior to dosing until completion of the follow up visit. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Key exclusion criteria (25 listed)
- History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Abnormal blood pressure as determined by the investigator or designee
- Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention, or any other condition that may place the participant at risk, in the opinion of the investigator.
- Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening.
- Use of any systemic antibiotic within 30 days of screening.
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 |
|---|---|---|
| GepotidacinGepotidacin will be administered | Drug | Participants receiving gepotidacin powder for oral suspension followed by tablet, Participants receiving gepotidacin tablet followed by powder for oral suspension |
Primary outcome
Periods 1 and 2: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Blood samples will be collected for the concentrations of gepotidacin
Periods 1 and 2: AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Blood samples will be collected for the concentrations of gepotidacin
Periods 1 and 2: Maximum observed plasma concentration (Cmax) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Blood samples will be collected for the concentrations of gepotidacin
12 secondary outcomes
Periods 1 and 2: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 14 days
Periods 1 and 2: Maximum change from Baseline in QT interval corrected with Fridericia's method (QTcF)
Time frame: Baseline and up to 14 days
Periods 1 and 2: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Absorption lag time (Tlag) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Terminal phase half-life (t1/2) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Apparent volume of distribution (Vz/F) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Relative bioavailability (Frel) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Apparent oral clearance (CL/F) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: AUC from time zero to 24 hours (AUC[0-24]) of gepotidacin
Time frame: Up to 24 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Total unchanged drug (Ae total) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
Periods 1 and 2: Renal clearance of drug (CLr) of gepotidacin
Time frame: Up to 48 hours post dose in each period (each period is 3 days)
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 30 Jan 2023.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Gepotidacin in people with Healthy Volunteers, run by GlaxoSmithKline 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 5 inclusion and 25 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 30 Jan 2023. 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?
Periods 1 and 2: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin (time frame: Up to 48 hours post dose in each period (each period is 3 days)). The study lists 3 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 30 Jan 2023.