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

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Brief Title

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

Official Title

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

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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of Adverse Events [Safety and Tolerability]

Secondary Outcome

 Maximum Plasma Concentration [Cmax]

Condition

Pruritus

Intervention

EP547

Study Arms / Comparison Groups

 EP547 Single Dose
Description:  Single doses of EP547

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

89

Start Date

September 7, 2020

Completion Date

June 30, 2021

Primary Completion Date

June 30, 2021

Eligibility Criteria

        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 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 Criteria:

        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)
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT04510090

Organization ID

EP-547-101


Responsible Party

Sponsor

Study Sponsor

Escient Pharmaceuticals, Inc

Collaborators

 Novotech (Australia) Pty Limited

Study Sponsor

, , 


Verification Date

June 2021