PruritusPhase 1NCT04510090
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
A Phase 1 study testing EP547 in people with Pruritus and Cholestasis, run by Escient Pharmaceuticals, Inc at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus, Cholestasis, Kidney Failure
- What is being tested?
- EP547
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 7 Sep 2020to 8 Jul 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
CMAX Clinical Research
Adelaide, South Australia, 5000
Monash Medical Centre
Clayton, Victoria, 3168
The Alfred Hospital
Melbourne, Victoria, 3004
About this study
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
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.
Read the 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.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Being tested
- EP547, Placebo
- Medical subject headings
- Pruritus, Cholestasis, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP547Drug
EP547
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| EP547 Single Dose | Experimental | Single doses of EP547 Receives: Drug: EP547 |
| EP547 Multiple Doses | Experimental | Multiple doses of EP547 Receives: Drug: EP547 |
| Placebo Single Dose | Placebo comparator | Single doses of placebo Receives: Drug: Placebo |
| Placebo Multiple Doses | Placebo comparator | Multiple doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
To assess safety and tolerability of EP547 following single and multiple oral administration
Measured: Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
Secondary outcomes (2)
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
To evaluate the pharmacokinetics of single dose of EP547
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, and 12 hours post-dose on Day 1
Maximum Plasma Concentration [Cmax] After Multiple Doses of EP547
To evaluate the pharmacokinetics of multiple doses of EP547
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start7 Sep 2020
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escient Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510090
- Sponsor's protocol ID
- EP-547-101
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2020
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04510090
- Acronym / sponsor ID
- EP-547-101
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Escient Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EP547 Single Dose | Experimental | Drug: EP547Single doses of EP547 |
| EP547 Multiple Doses | Experimental | Drug: EP547Multiple doses of EP547 |
| Placebo Single Dose | Placebo comparator | Drug: PlaceboSingle doses of placebo |
| Placebo Multiple Doses | Placebo comparator | Drug: PlaceboMultiple doses of placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- Age 18 to 80 years, inclusive
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP547EP547 | Drug | EP547 Multiple Doses, EP547 Single Dose |
| PlaceboPlacebo | Drug | Placebo Multiple Doses, Placebo Single Dose |
Primary outcome
Incidence of Adverse Events
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)
To assess safety and tolerability of EP547 following single and multiple oral administration
2 secondary outcomes
Maximum Plasma Concentration [Cmax] After Single Dose of EP547
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, and 12 hours post-dose on Day 1
Maximum Plasma Concentration [Cmax] After Multiple Doses of EP547
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EP547 in people with Pruritus and Cholestasis, run by Escient Pharmaceuticals, Inc at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Measured from Day 1 to End of Study or Early Termination (up to 3 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.