At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 89 enrolled
Drug / intervention
EP547 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating EP547 and Placebo for Pruritus and 2 related conditions. Completed, enrolled 89 participants across 4 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPruritus, Cholestasis, Kidney Failure
CountriesAustralia, New Zealand
CollaboratorsNovotech (Australia) Pty Limited
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartSep 2020
Primary CompletionJul 2021
TodayJul 2026
First PostedAug 12, 2020
Enrollment StartSep 7, 2020
Primary CompletionJul 8, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.9 years ago
Interventions
EP547drug
EP547
Placebodrug
Placebo