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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04510090




Registration number
NCT04510090
Ethics application status
Date submitted
7/08/2020
Date registered
12/08/2020

Titles & IDs
Public title
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
Scientific 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
Secondary ID [1] 0 0
EP-547-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pruritus 0 0
Cholestasis 0 0
Kidney Failure 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 0 0 0 0
Kidney disease
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EP547
Treatment: Drugs - Placebo

Experimental: EP547 Single Dose - Single doses of EP547

Experimental: EP547 Multiple Doses - Multiple doses of EP547

Placebo comparator: Placebo Single Dose - Single doses of placebo

Placebo comparator: Placebo Multiple Doses - Multiple doses of placebo


Treatment: Drugs: EP547
EP547

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events
Timepoint [1] 0 0
Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Secondary outcome [1] 0 0
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
Timepoint [1] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, and 12 hours post-dose on Day 1
Secondary outcome [2] 0 0
Maximum Plasma Concentration [Cmax] After Multiple Doses of EP547
Timepoint [2] 0 0
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, and 24 hours post-dose on Day 7

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/07/2021
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Escient Pharmaceuticals, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04510090