| Primary | Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC) | Measured by qRT-PCR in nasal samples. | Intent-to-treat infected (ITT-I) Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | log10 copies/mL*hours | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00099.05± 133.325
- OG00182.28± 158.033
- OG002657.45± 396.743
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| High Dose versus (vs) Placebo | ANCOVA | | <0.0001 | | Difference in least square (LS) means | -540.56 | | | 2-Sided | 95 | -680.80 | -400.33 | | | | | Superiority | P-values are from analysis of covariance (ANCOVA) with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP. | | |
|
| Secondary | qRT-PCR: RSV Peak Viral Load (VLPEAK) | Measured by qRT-PCR in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK | Measured by qRT-PCR in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity | The time from the assessment at the time of the first dose of IMP to qRT-viral load negativity was analyzed using the Kaplan-Meier method. Viral load negativity was reached at the first time when the viral load was undetectable (< lower limit of detection [LLOD]) by qRT-PCR, after which no further detectable assessment appeared. Measured by qRT-PCR in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data. | Posted | | Median | 95% Confidence Interval | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
|
| Secondary | qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load | Time to first negative slope = time of the timepoint after which there are two consecutive declines in viral load - time of the nearest viral load assessment to the first dose of IMP. Measured by qRT-PCR in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during qRT-PCR. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
|
| Secondary | qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 High Dose | Calculated as the slope of the RSV viral load over time from time of RSV VLPEAK to 1, 2, 3, and 4 days later. Estimates for fixed effects of a mixed linear model, modeling the viral load from peak up to the 4 following days, with time from VLPEAK, group and interaction between time and group as fixed effects and a random intercept within each participant. The model was a distinct analysis for the EDP-323 high dose and placebo groups where the estimates for both groups are model-dependent and impacted by the overall model. A negative slope indicated that the viral load decreased over time. Measured by qRT-PCR in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during qRT-PCR. | Posted | | Number | 95% Confidence Interval | log10 copies/mL/day | | Up to Day 16 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | qRT-PCR: RSV Viral Load Clearance Rate - EDP-323 Low Dose | Calculated as the slope of the RSV viral load over time from time of RSV VLPEAK to 1, 2, 3, and 4 days later. Estimates for fixed effects of a mixed linear model, modeling the viral load from peak up to the 4 following days, with time from VLPEAK, group and interaction between time and group as fixed effects and a random intercept within each participant. The model was a distinct analysis for the EDP-323 low dose and placebo groups where the estimates for both groups are model-dependent and impacted by the overall model. A negative slope indicated that the viral load decreased over time. Measured by qRT-PCR in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during qRT-PCR. | Posted | | Number | 95% Confidence Interval | log10 copies/mL/day | | Up to Day 16 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG001 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
|
| Secondary | Viral Culture: RSV VL-AUC | Measured by viral culture (plaque assay) in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | log10 plaque-forming units (PFU)/mL*h | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | Viral Culture: RSV VLPEAK | Measured by viral culture (plaque assay) in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | log10 PFU/mL | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK | Measured by viral culture (plaque assay) in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity | Measured by viral culture (plaque assay) in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data. | Posted | | Median | 95% Confidence Interval | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | Viral Culture: Time From the Assessment at the Time of the First Dose of IMP to First Negative Slope of RSV Viral Load | Measured by viral culture (plaque assay) in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during plaque assay. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | Viral Culture: RSV Viral Load Clearance Rate | Calculated as the slope of the RSV viral load over time from time of RSV VLPEAK to 1, 2, 3, and 4 days later. Estimates for fixed effects of a mixed linear model, modeling the viral load from peak up to the 4 following days, with time from VLPEAK, group and interaction between time and group as fixed effects and a random intercept within each participant. A negative slope indicated that the viral load decreased over time. Measured by viral culture in nasal samples. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with at least one detectable viral load during plaque assay. | Posted | | Number | 95% Confidence Interval | log10 PFU/mL/day | | Up to Day 16 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo |
|
| Secondary | Area Under the Total Symptom Score (TSS)-Time Curve (TSS-AUC) | An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3:
- Runny nose
- Stuffy nose
- Sneezing
- Sore throat
- Earache
- Malaise/Tiredness
- Headache
- Muscle and/or Joint Ache
- Cough
- Shortness of breath
TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome. The calculation of the TSS-AUC was performed on the TSS measured 3 times a day using the trapezoidal summation rule based on actual time intervals in hours. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | score*hours | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 |
|
| Secondary | Peak TSS | Defined as the highest recorded value of TSS. An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3:
- Runny nose
- Stuffy nose
- Sneezing
- Sore throat
- Earache
- Malaise/Tiredness
- Headache
- Muscle and/or Joint Ache
- Cough
- Shortness of breath
TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
|
| Secondary | Time to Peak TSS | Time to peak TSS = time of peak TSS - time of the nearest TSS assessment to the first dose of IMP. An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3:
- Runny nose
- Stuffy nose
- Sneezing
- Sore throat
- Earache
- Malaise/Tiredness
- Headache
- Muscle and/or Joint Ache
- Cough
- Shortness of breath
TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | |
|
| Secondary | Time to Resolution From Peak TSS | Time to resolution from peak TSS = time of the first 24-hour symptom-free time point - time of peak TSS. An individual TSS (10-items) was derived at each assessment of the diary card as the sum of the scores given to the 10 following symptoms on that symptom score card, giving a score between 0 and 3:
- Runny nose
- Stuffy nose
- Sneezing
- Sore throat
- Earache
- Malaise/Tiredness
- Headache
- Muscle and/or Joint Ache
- Cough
- Shortness of breath
TSS ranged from 0 to 30 with higher TSS indicating a higher disease burden and thus a worse outcome. | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive of participants with at least one TSS >0 only. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo |
|
| Secondary | Total Weight of Nasal Discharge (Mucus) Produced | Each participant was given pre-weighed packets of paper tissues. Participants were asked to place single tissues used for nose blowing or sneezing into a specified collection bag (for that participant only). | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data. | Posted | | Mean | Standard Deviation | grams | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | Total Number of Tissues Used | Each participant was given pre-weighed packets of paper tissues. Participants were asked to place single tissues used for nose blowing or sneezing into a specified collection bag (for that participant only). | ITT-I Analysis Set: All participants having received challenge virus, randomized, and having received at least one dose of IMP, and meeting the criterion for laboratory-confirmed RSV infection. Inclusive only of participants with available data. | Posted | | Mean | Standard Deviation | tissues | | Day 1 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
| |
| Secondary | Maximum Plasma Concentration (Cmax) | Plasma pharmacokinetic (PK) parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, below the limit of quantification (BQL) values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. | Posted | | Mean | Standard Deviation | ng/mL | | First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. |
|
| Secondary | Time to Cmax (Tmax) | Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. | Posted | | Median | Full Range | hours | | First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. |
|
| Secondary | Terminal Half-life (t1/2) | Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 low dose group had quantifiable samples for EP-039082 (below limit of quantification [BLQ]) for the analysis of this PK parameter. | Posted | | Mean | Standard Deviation | hours | | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose |
|
| Secondary | Apparent Systemic Clearance at Steady-state (CLss/F) | Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 high dose and EDP-323 low dose groups had quantifiable samples for EP-038725 and EP-039082 (BLQ) for the analysis of this PK parameter. | Posted | | Mean | Standard Deviation | L/h | | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose |
|
| Secondary | Terminal Elimination Rate Constant (λz) | Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 low dose group had quantifiable samples for EP-039082 (BLQ) for the analysis of this PK parameter. | Posted | | Mean | Standard Deviation | per hour | | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | |
|
| Secondary | Apparent Volume of Distribution at Steady-state (Vss/F) | Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The plasma PK parameters were estimated from the concentration-time profiles. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. No participants in the EDP-323 high dose and EDP-323 low dose groups had quantifiable samples for EP-038725 and EP-039082 (BLQ) for the analysis of this PK parameter. | Posted | | Mean | Standard Deviation | liters | | Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose), Day 2 pre-dose, Day 3 pre-dose, Day 4 pre-dose, Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose |
|
| Secondary | Plasma Concentration at 12 Hours (C12h) and 24 Hours (C24h) | In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. | Posted | | Mean | Standard Deviation | ng/mL | | First Dose: Day 1, 12 and 24 hours post-dose; Last Dose: Day 5, 12 and 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. |
| |
| Secondary | Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) | Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The AUCs were calculated using linear up/log down method. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. | Posted | | Mean | Standard Deviation | h*ng/mL | | First Dose: Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 15 hours post-dose) and Day 2 pre-dose; Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. |
|
| Secondary | Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau) | Plasma PK parameters for EDP-323 and metabolites (EP-038725 and EP-039082) were estimated using non-compartmental methods. The AUCs were calculated using linear up/log down method. In estimating the PK parameters, BQL values were set to zero. Actual sampling times, rather than scheduled sampling times, were used in all computations involving sampling times. If the actual time or dose time was missing, the scheduled time could be substituted in order to calculate the PK parameter. In case of an actual sampling time deviating by >20% from the scheduled (nominal) time, this plasma concentration was excluded from descriptive statistics in the plasma concentration-time table. | PK Analysis Set: All ITT analysis set participants with at least one post-dose PK result. Inclusive only of participants with available data for each analyte and timepoint. | Posted | | Mean | Standard Deviation | h*ng/mL | | Last Dose: Day 5 (pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, 48, 60, and 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. |
|
| Secondary | Number of Participants With Adverse Events (AEs) up to Discharge | An AE was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical (investigational or non-investigation) product. An AE does not necessarily have a causal relationship with the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose:
- Resulted in death
- Was life threatening
- Required inpatient hospitalization or prolongation of existing hospitalization
- Resulted in persistent disability/incapacity
- Was a congenital anomaly/birth defect
- Was an important medical event
| Safety Analysis Set (Treated Participants): All participants having received challenge virus and IMP. | Posted | | Count of Participants | | Participants | | Day -2 to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | |
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events | An AE was defined as any untoward medical occurrence in clinical study participants administered a pharmaceutical (investigational or non-investigation) product. An AE does not necessarily have a causal relationship with the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose:
- Resulted in death
- Was life threatening
- Required inpatient hospitalization or prolongation of existing hospitalization
- Resulted in persistent disability/incapacity
- Was a congenital anomaly/birth defect
- Was an important medical event
| Safety Analysis Set (Treated Participants): All participants having received challenge virus and IMP. | Posted | | Count of Participants | | Participants | | Day 1 to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | EDP-323 High Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered 600 mg EDP-323 QD for 5 days. | | OG001 | EDP-323 Low Dose | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered loading dose 600 mg EDP-323 on Day 1 followed by 200 mg EDP-323 QD for the remaining 4 days. | | OG002 | Placebo | Participants received RSV-A Memphis 37b virus inoculation on Day 0 then orally administered matching placebo QD for 5 days. |
|