Status:
COMPLETED
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
Lead Sponsor:
Escient Pharmaceuticals, Inc
Collaborating Sponsors:
Novotech (Australia) Pty Limited
Conditions:
Pruritus
Cholestasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 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
Exclusion
- 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:
- Scheduled to receive a liver transplant during the study (placement on a transplant waiting list is not exclusionary)
- 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:
- Scheduled to receive a kidney transplant during the study (placement on a transplant waiting list is not exclusionary)
- 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)
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04510090
Start Date
September 7 2020
End Date
July 8 2021
Last Update
August 8 2025
Active Locations (4)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
2
Monash Medical Centre
Clayton, Victoria, Australia, 3168
3
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
4
Auckland Clinical Studies (ACS)
Grafton, Auckland, New Zealand, 1010