At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Apraglutidedrug
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.
A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Apraglutide for Hepatic Impairment. Completed, enrolled 16 participants across 2 sites in 2 countries.
Detailed Summary
The primary objective is to assess the pharmacokinetics (PK) of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single subcutaneous (SC) dose administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesGermany, Slovakia
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
Enrollment StartJan 2023
First PostedJan 2023
Primary CompletionApr 2023
TodayJul 2026
First PostedJan 31, 2023
Enrollment StartJan 30, 2023
Primary CompletionApr 4, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.4 years ago
Interventions
Apraglutidedrug
Single dose of apraglutide