NCT04510090

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

Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Escient Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study consists of both single and multiple ascending doses in healthy subjects and in subjects with cholestatic or uremic pruritus. Up to 48 healthy subjects will receive a single dose of EP547 or placebo. There will be a screening period of up to 28 days prior to the first dose, and a follow up visit 7 days after dosing is completed. 24 healthy subjects will receive multiple doses of EP547 or placebo for 7 days. There will be a screening period of up to 28 days prior to the first dose, and a follow up visit 7 days and then 14 days after dosing is completed. 6 subjects with cholestatic disease will receive a single dose of EP547. There will be a screening period of up to 28 days prior to the first dose, and a follow up visit 7 days after dosing is completed. Up to 16 subjects with cholestatic pruritus will receive multiple doses of EP547 or placebo for 7 days. There will be a screening period of up to 28 days prior to the first dose, and a follow up visit 7 days and then 14 days after dosing is completed. 6 subjects with uremic disease will receive a single dose of EP547. There will be a screening period of up to 28 days prior to the first dose, and a follow up visit 7 days after dosing is completed. Up to 16 subjects with uremic pruritus will receive multiple doses of EP547 or placebo for 7 days. There will be a screening period of up to 28 days prior to the first dose, and a follow up visit 7 days and then 14 days after dosing is completed. 12 healthy subjects will receive two doses of EP547 under fasted or fed condition.

Conditions

• Pruritus
• Cholestasis
• Kidney Failure

Interventions

Type	Name	Description
DRUG	EP547	EP547
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-09-07
• Primary completion: 2021-07-08
• Completion: 2021-07-08
• First posted: 2020-08-12
• Last updated: 2025-08-08
• Results posted: 2023-06-12

Locations

4 sites across 2 countries: Australia, New Zealand