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Completed

NCT Number: NCT03691623

A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model

A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.

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Key information

Conditions

RSV Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

hVIVO Services Limited (hVIVO)

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An informed consent document signed and dated by the subject
  • Age 18 to 55 years, inclusive
  • In good health with no history of major medical conditions
  • A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m^2 and ≤ 30kg/m^2

Exclusion criteria

  • Pregnant or nursing females
  • Acute or chronic medical illness
  • Abnormal lung function
  • Positive for human immunodeficiency virus (HIV), active hepatitis A, B or C test
  • Nose or nasopharynx abnormalities
  • Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug

Treatment and study plan

EDP-938 Dose 1

Drug

Oral suspension for 5 days

EDP-938 Dose 2

Drug

Oral suspension for 5 days

Placebo

Drug

Oral suspension for 5 days

EDP-938 Dose 3

Drug

Oral suspension for 5 days

EDP-938 Dose 4

Drug

Oral suspension for 5 days

Primary outcomes

  1. Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load

    Time frame: Twice daily on Day 2 through Day 11 and once on Day 12

    Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.

Secondary outcomes

  1. Area Under the Curve (AUC) of Total Symptom Score

    Time frame: Three times daily on Day 0 to Day 11, once on Day 12

    Total symptom scores (from the 10-item Diary Card) were used to calculate the AUC. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities:

    • Runny nose
    • Stuffy nose
    • Sneezing
    • Sore throat
    • Earache
    • Malaise (Tiredness)
    • Cough
    • Shortness of breath
    • Headache
    • Muscle/ joint ache/ stiffness

    Total symptom score is the sum of individual symptom scores with a potential range of 0 (best) to 30 (worst). Data presented is hours x score.

  2. Peak Total Symptom Score

    Time frame: Day 2 to Day 12

    Peak total symptom score was defined as the highest total symptom score between first dose of study drug and Day 12. Values presented are a sum of individual symptom scores, with a potential range of 0 (best) to 30 (worst). Total symptom scores at the time of the first dose of study drug can be before or after dosing.

    Measured by the 10-item Diary Card. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities:

    • Runny nose
    • Stuffy nose
    • Sneezing
    • Sore throat
    • Earache
    • Malaise (Tiredness)
    • Cough
    • Shortness of breath
    • Headache
    • Muscle/ joint ache/ stiffness

  3. Total Symptom Score

    Time frame: Day 2 to Day 9

    Measured by the 10-item Diary Card. Each individual symptom score was graded on a scale of 0-3, where Grade 0 is absence, Grade 1 is just noticeable, Grade 2 is bothersome but does not prevent participation in activities and Grade 3 is bothersome and interferes with activities. Total symptom score is the sum of individual symptom scores with a potential range of 0 (best) to 30 (worst).

    • Runny nose
    • Stuffy nose
    • Sneezing
    • Sore throat
    • Earache
    • Malaise (Tiredness)
    • Cough
    • Shortness of breath
    • Headache
    • Muscle/ joint ache/ stiffness

  4. Time to Peak Total Symptom Score

    Time frame: Day 2 to Day 12

    Time to peak total symptom score was defined as the time in days to the highest total symptom score between first dose of study drug and Day 12. Total symptom scores at the time of the first dose of study drug can be before or after dosing.

  5. Time to Resolution From Peak Total Symptom Score

    Time frame: Day 2 to Day 12

    Time to resolution from peak total symptom score was defined as the time in days from the highest total symptom score (between first dose of study drug and Day 12) until the start of the first 24-hour symptom-free period (after the highest total symptom score). Total symptom scores at the time of the first dose of study drug can be before or after dosing.

  6. Total Weight of Nasal Mucus Produced

    Time frame: Day 2 to Day 12

    Measured via weighed paper tissues and reported as a mean total across all study days.

  7. Peak Viral Load

    Time frame: Day 2 to Day 12

    Peak viral load was defined as the highest quantitative reverse transcription polymerase chain reaction (RT-qPCR) viral load value between first dose of study drug and Day 12. Measured by nasal wash RT-qPCR.

  8. Time to Peak Viral Load

    Time frame: Day 2 to Day 12

    Time to peak viral load was defined as the time to the highest quantitative reverse transcription polymerase chain reaction (RT-qPCR) viral load value between first dose of study drug and Day 12. Measured by nasal wash RT-qPCR.

  9. Time to Resolution From Peak Viral Load

    Time frame: Day 2 to Day 12

    Time to resolution from peak viral load was defined as the time from peak until first confirmed undetectable assessment between first dose of study drug and Day 12. Measured by by nasal wash quantitative reverse transcription polymerase chain reaction (RT-qPCR).

  10. Time to Cessation of Virus Detection

    Time frame: Day 2 to Day 12

    Time to cessation of virus detection was measured by nasal wash quantitative reverse transcription polymerase chain reaction (RT-qPCR).

  11. Safety and Tolerability as Assessed by Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 2 to Day 28

    A TEAE was defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant physical examinations, vital signs, clinical laboratory tests (including biochemistry, hematology, coagulation [if required], cardiac enzymes and urine analysis), 12-lead electrocardiograms (ECGs) and spirometry results were recorded as adverse events.

  12. Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites

    Time frame: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  13. Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites

    Time frame: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  14. Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites

    Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  15. Apparent Systemic Clearance at Steady State (CLss/F) of EDP-938

    Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

  16. Terminal Phase Rate Constant Calculated by Linear Regression of the Terminal Loglinear Portion of the Concentration vs. Time Curve (λz) of EDP-938 and Its Metabolites

    Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  17. Volume of Distribution at Steady State (Vss/F) of EDP-938

    Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

  18. Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites

    Time frame: Day 2 and Day 7; 12 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  19. Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites

    Time frame: Day 2 and Day 7; 24 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  20. Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites

    Time frame: Day 2: pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose; and Day 7: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  21. Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites

    Time frame: Day 2 and Day 6: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Day 7 only: 15, 24, 30, 36, 48, 60, and 72 hours post-dose

    The metabolites of EDP-938 that were assessed were EP-024636, EP-024594 and EP-024595.

  22. Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Viral Load AUC

    Time frame: Day 2 to Day 18

    The overall criteria to define correlation was based on identifying a PK AUC associated with a less favorable viral load AUC i.e. a low PK AUC and a high viral load AUC indicated a correlation.

  23. Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Total Symptom Score (TSS) AUC

    Time frame: Day 2 to Day 18

    The overall criteria to define correlation was based on identifying a PK AUC associated with a less favorable TSS AUC, i.e. a low PK AUC and a high TSS AUC indicated a correlation.

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Collaborators

  • hVIVO Services Limited

Registry information

Official study title

A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-938 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2018
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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