NCT03691623
Completed
Phase 2
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.
ConditionsRSV Infection
Overview
- Phase
- Phase 2
- Intervention
- EDP-938 Dose 3
- Conditions
- RSV Infection
- Sponsor
- Enanta Pharmaceuticals, Inc
- Enrollment
- 179
- Locations
- 1
- Primary Endpoint
- Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
EDP-938 Arm D
Subjects will take EDP-938 Dose 3 oral suspension for 5 days
Intervention: EDP-938 Dose 3
EDP-938 Arm E
Subjects will take EDP-938 Dose 4 oral suspension for 5 days
Intervention: EDP-938 Dose 4
Placebo Arm C
Subjects will take matching placebo oral suspension for 5 days
Intervention: Placebo
EDP-938 Arm A
Subjects will take EDP-938 Dose 1 oral suspension for 5 days
Intervention: EDP-938 Dose 1
EDP-938 Arm B
Subjects will take EDP-938 Dose 2 oral suspension for 5 days
Intervention: EDP-938 Dose 2
Placebo Arm F
Subjects will take matching placebo oral suspension for 5 days
Intervention: Placebo
Outcomes
Primary Outcomes
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
- Area Under the Curve (AUC) of Total Symptom Score(Three times daily on Day 0 to Day 11, once on Day 12)
- Time to Resolution From Peak Total Symptom Score(Day 2 to Day 12)
- Terminal Phase Half-Life (t1/2) of EDP-938 and Its Metabolites(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)
- Plasma Concentration at 24 Hours (C24) of EDP-938 and Its Metabolites(Day 2 and Day 7; 24 hours post-dose)
- Maximum Plasma Concentration (Cmax) of EDP-938 and Its Metabolites(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)
- Time to Resolution From Peak Viral Load(Day 2 to Day 12)
- Time to Cessation of Virus Detection(Day 2 to Day 12)
- Time to Peak Total Symptom Score(Day 2 to Day 12)
- Total Weight of Nasal Mucus Produced(Day 2 to Day 12)
- Apparent Systemic Clearance at Steady State (CLss/F) of EDP-938(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)
- Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Viral Load AUC(Day 2 to Day 18)
- Peak Total Symptom Score(Day 2 to Day 12)
- Peak Viral Load(Day 2 to Day 12)
- Time to Peak Viral Load(Day 2 to Day 12)
- Safety and Tolerability as Assessed by Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Day 2 to Day 28)
- Total Symptom Score(Day 2 to Day 9)
- Time to Maximum Plasma Concentration (Tmax) of EDP-938 and Its Metabolites(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)
- Volume of Distribution at Steady State (Vss/F) of EDP-938(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)
- Plasma Concentration at 12 Hours (C12) of EDP-938 and Its Metabolites(Day 2 and Day 7; 12 hours post-dose)
- Area Under the Concentration Time Curve Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of EDP-938 and Its Metabolites(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)
- Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of EDP-938 and Its Metabolites(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)
- 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(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)
- Number of Participants With Correlation of Plasma Pharmacokinetic (PK) Area Under the Curve (AUC) and Total Symptom Score (TSS) AUC(Day 2 to Day 18)
Study Sites (1)
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