Trial Outcomes & Findings for Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract (NCT NCT04633187)

NCT ID: NCT04633187

Last Updated: 2024-08-22

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: Day 1 through Day 28
• Results posted on: 2024-08-22

Participant Flow

Participant milestones

Measure	EDP-938 EDP-938 150mg/400mg/800mg	Placebo Placebo
Overall Study STARTED	5	4
Overall Study EDP-938 150 mg	1	0
Overall Study EDP-938 400 mg	1	0
Overall Study EDP-938 800 mg	3	0
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract

Baseline characteristics by cohort

Measure	EDP-938 n=5 Participants EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose	Placebo n=4 Participants Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days	Total n=9 Participants Total of all reporting groups
Age, Continuous	44.4 Years STANDARD_DEVIATION 15.98 • n=5 Participants	44.3 Years STANDARD_DEVIATION 15.99 • n=7 Participants	44.3 Years STANDARD_DEVIATION 14.95 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 28

Outcome measures

Measure	EDP-938 n=5 Participants EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose.	Placebo n=4 Participants Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 49

Population: Six participants (3 in each treatment group) had detectable RSV by RT-qPCR at baseline and were included in the mITT by RT-qPCR analysis population.

Outcome measures

Measure	EDP-938 n=3 Participants EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose.	Placebo n=3 Participants Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Change From Baseline in RSV RNA Viral Load	-7.072 RSV viral load (log10 copies/mL) Standard Deviation 0.7738	-2.221 RSV viral load (log10 copies/mL) Standard Deviation 6.8552

SECONDARY outcome

Timeframe: Day 1 through Day 49

Outcome measures

Measure	EDP-938 n=5 Participants EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose.	Placebo n=4 Participants Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Proportion of Subjects Progressing to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 49

Outcome measures

Measure	EDP-938 n=5 Participants EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose.	Placebo n=4 Participants Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Safety as Measured the Number of Participants With at Least One Treatment-emergent Adverse Event	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose

Population: Pharmacokinetic (PK) Population, PK data for subjects who received EDP-938 800 mg doses. If more than 50% of subjects have post dose concentration values below the limit of quantification (BLQ), descriptive statistics are not presented.

Outcome measures

Measure	EDP-938 n=3 Participants EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose.	Placebo Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Plasma PK Concentrations of EDP-938 800mg Day 1 Predose	0 ng/mL Standard Deviation 0	—
Plasma PK Concentrations of EDP-938 800mg Day 1 Postdose	1123.33 ng/mL Standard Deviation 1028.899	—
Plasma PK Concentrations of EDP-938 800mg Day 4 Predose	1610.00 ng/mL Standard Deviation 175.784	—
Plasma PK Concentrations of EDP-938 800mg Day 7 Predose	1342.33 ng/mL Standard Deviation 411.554	—
Plasma PK Concentrations of EDP-938 800mg Day 7 Postdose	1394.33 ng/mL Standard Deviation 493.504	—
Plasma PK Concentrations of EDP-938 800mg Day 11 Predose	1176.67 ng/mL Standard Deviation 204.287	—
Plasma PK Concentrations of EDP-938 800mg Day 16 Predose	860.00 ng/mL Standard Deviation 411.887	—
Plasma PK Concentrations of EDP-938 800mg Day 21 Predose	755.33 ng/mL Standard Deviation 58.011	—
Plasma PK Concentrations of EDP-938 800mg Day 21 Postdose	1136.00 ng/mL Standard Deviation 656.195	—

Adverse Events

EDP-938

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	EDP-938 n=5 participants at risk EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose.	Placebo n=4 participants at risk Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Hepatobiliary disorders Hypertransaminasaemia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Mucosal infection	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.

Other adverse events

Measure	EDP-938 n=5 participants at risk EDP-938: EDP-938 150/400/800mg The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose.	Placebo n=4 participants at risk Placebo: Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
Metabolism and nutrition disorders Hypokalaemia	40.0% 2/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Hypomagnesaemia	40.0% 2/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Cellulitis	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Conjunctivitis	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Cytomegalovirus hepatitis	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Cytomegalovirus infection	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Cytomegalovirus infection reactivation	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Epstein-Barr virus infection reactivation	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Folliculitis	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Pneumonia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Sepsis	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Upper respiratory tract infection	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Infections and infestations Urinary tract infection	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Calcium deficiency	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Decreased appetite	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Hypocalcaemia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Hyponatraemia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Vitamin C deficiency	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Vitamin D deficiency	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Metabolism and nutrition disorders Zinc deficiency	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Gastrointestinal disorders Nausea	40.0% 2/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Gastrointestinal disorders Stomatitis	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Gastrointestinal disorders Swollen tongue	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Gastrointestinal disorders Vomiting	40.0% 2/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
General disorders Asthenia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
General disorders Oedema peripheral	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
General disorders Pain	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
General disorders Pyrexia	40.0% 2/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Blood and lymphatic system disorders Anaemia of chronic disease	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Respiratory, thoracic and mediastinal disorders Dyspnoea	40.0% 2/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Respiratory, thoracic and mediastinal disorders Productive cough	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Cardiac disorders Palpitations	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Ear and labyrinth disorders Middle ear inflammation	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	25.0% 1/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Investigations Alanine aminotransferase increased	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Investigations Gamma-glutamyltransferase increased	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Nervous system disorders Cerebellar infarction	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Nervous system disorders Intensive care unit acquired weakness	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Psychiatric disorders Anxiety	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Psychiatric disorders Hallucination	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Psychiatric disorders Insomnia	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Renal and urinary disorders Renal impairment	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.
Vascular disorders Hypertension	20.0% 1/5 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.	0.00% 0/4 • Adverse event data was collected beginning on Day 1 and concluded at the End-of-Study (EOS) visit on Day 49, 28 days following the last dose of the study drug. The EDP-938 doses were adjusted to account for inhibitory effects of Azole antifungals on hepatic metabolism, and EDP-938 doses of 150mg and 400mg; when EDP-938 is co-administered with azole antifungals that are strong or moderate CYP3A4 inhibitors, respectively, provide similar exposures to the 800mg dose. Adverse Events are presented for all dosages combined because, as noted above, subjects had an equivalent exposure across all EDP-938 doses administered.

Additional Information

Study Director

Enanta Pharmaceuticals

Phone: 617-607-0800

Email: enquiries@enanta.com

Results disclosure agreements

• Principal investigator is a sponsor employee There is an agreement between the Principal Investigators and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed.
• Publication restrictions are in place

Restriction type: OTHER