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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510090
Recruitment Status : Active, not recruiting
First Posted : August 12, 2020
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
Escient Pharmaceuticals, Inc

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.

Condition or disease Intervention/treatment Phase
Pruritus Cholestasis Kidney Failure Drug: EP547 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 7, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Experimental: EP547 Single Dose
Single doses of EP547
Drug: EP547
EP547

Experimental: EP547 Multiple Doses
Multiple doses of EP547
Drug: EP547
EP547

Placebo Comparator: Placebo Single Dose
Single doses of placebo
Drug: Placebo
Placebo

Placebo Comparator: Placebo Multiple Doses
Multiple doses of placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: Measured from Day 1 to End of Study or Early Termination (up to 3 weeks) ]
    Safety and tolerability of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus measured through adverse events.


Secondary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] [ Time Frame: Measured from Day 1 to End of Study (up to 3 weeks) ]
    To evaluate the pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510090


Locations
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Australia, South Australia
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
New Zealand
Auckland Clinical Studies (ACS)
Grafton, Auckland, New Zealand, 1010
Sponsors and Collaborators
Escient Pharmaceuticals, Inc
Novotech (Australia) Pty Limited
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Responsible Party: Escient Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04510090    
Other Study ID Numbers: EP-547-101
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholestasis
Renal Insufficiency
Pruritus
Kidney Diseases
Urologic Diseases
Skin Diseases
Skin Manifestations
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases