Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus

NCT04510090 | Completed Phase 1 Results DMC

• 1 other identifier: EP-547-101
• Study Type: interventional
• Target: 89
• Locations: 2 countries
• Sites: 4

Brief Summary

This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.

Conditions

Pruritus; Cholestasis; Kidney Failure

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  To assess safety and tolerability of EP547 following single and multiple oral administration

  Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)

Secondary Outcomes (2)

• Maximum Plasma Concentration [Cmax] After Single Dose of EP547

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, and 12 hours post-dose on Day 1

• Maximum Plasma Concentration [Cmax] After Multiple Doses of EP547

  Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, and 24 hours post-dose on Day 7

Study Arms (4)

EP547 Single Dose

EXPERIMENTAL

Single doses of EP547

Drug: EP547

EP547 Multiple Doses

EXPERIMENTAL

Multiple doses of EP547

Drug: EP547

Placebo Single Dose

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebo

Placebo Multiple Doses

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebo

Interventions

EP547 DRUG

EP547

EP547 Multiple Doses; EP547 Single Dose

Placebo DRUG

Placebo

Placebo Multiple Doses; Placebo Single Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Subjects:
• Age 18 to 60 years, inclusive
• Body mass index greater than or equal to 19 to less than or equal to 35 kg/m2
• Medically healthy with no clinically significant medical history, physical examination, vital sign, standard 12- lead ECG, chemistry, hematology, urinalysis, or coagulation results at Screening as deemed by the Investigator
• Male and female subjects must use adequate birth control and agree not to donate sperm or eggs for the time periods specified in the protocol
• Subjects with Cholestatic Pruritus:
• Age 18 to 80 years, inclusive
• Has a cholestatic disorder
• Has experienced daily or near-daily moderate to severe pruritus for greater than 4 weeks before Screening and at study entry has itch scores indicative of moderate to severe pruritus
• If currently taking medications to treat the cholestatic disorder, must be on a stable dose for greater than 12 weeks before Screening and plans to maintain the regimen throughout the study
• If currently taking medications known to impact pruritus, must be on a stable dose for greater than 4 weeks before Screening and plans to maintain the regimen throughout the study
• Male and female subjects must use adequate birth control and agree not to donate sperm or eggs for the time periods specified in the protocol
• Subjects with Uremic Pruritus
• Age 18 to 80 years, inclusive
• Has ESRD and is receiving hemodialysis 3× per week

You may not qualify if:

• Healthy Subjects:
• Any prescription medications within 14 days of Screening
• Positive result for HIV HBV, or HCV at Screening
• History of malignancy within the past 5 years
• Tobacco product or electronic cigarette use within 90 days of Day -1
• Positive drug, alcohol, or cotinine screen results at Screening or Day -1
• Significant history of abuse of drugs, solvents, or alcohol in the past 2 years
• Subjects with Cholestatic Pruritus:
• Is receiving ongoing UVB treatment or anticipates receiving such treatment during the study
• Pruritus is secondary to biliary obstruction
• History or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein Thrombosis
• Subjects with Uremic Pruritus:
• Is receiving ongoing UVB treatment or anticipates receiving such treatment during the study
• Known noncompliance with hemodialysis treatment that, in the opinion of the Investigator, would impede completion or validity of the study
• Pruritus is attributed mainly to any disease unrelated to kidney disease, is only present during the hemodialysis sessions, or is attributed to a skin disorder that occurs in this population with associated itch (eg, acquired perforating dermatosis)

Sponsors & Collaborators

• Escient Pharmaceuticals, Inc: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (4)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Auckland Clinical Studies (ACS)

Grafton, Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

Pruritus; Cholestasis; Renal Insufficiency

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Kristin Taylor, Sr VP, Head of Clinical Development
• Organization: Escient Pharmaceuticals

clinicaltrials@escientpharma.com

(858) 617-8220

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 12, 2020
• Study Start: September 7, 2020
• Primary Completion: July 8, 2021
• Study Completion: July 8, 2021
• Last Updated: August 8, 2025
• Results First Posted: June 12, 2023

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (3)