Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholesta… (NCT04510090) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
Australia, New Zealand89 participantsStarted 2020-09-07
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
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 pr…
What they're measuring
1
Incidence of Adverse Events
Timeframe: Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)