A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants

NCT05271799 | Completed Phase 1 FDA Drug

• 1 other identifier: 207729
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Gepotidacin; Relative Bioavailability; Healthy participants

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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)

  Up to 14 days

• Periods 1 and 2: Maximum change from Baseline in QT interval corrected with Fridericia's method (QTcF)

  Baseline and up to 14 days

• Periods 1 and 2: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin

  Up to 48 hours post dose in each period (each period is 3 days)

• Periods 1 and 2: Absorption lag time (Tlag) of gepotidacin

  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

  Up to 48 hours post dose in each period (each period is 3 days)

Study Arms (2)

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

Interventions

Gepotidacin DRUG

Gepotidacin will be administered

Participants receiving gepotidacin powder for oral suspension followed by tablet; Participants receiving gepotidacin tablet followed by powder for oral suspension

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Interventions

gepotidacin

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a two periods, crossover study

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: March 1, 2022
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (1)