VectivBio AG
The primary objective is to assess the PK of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single SC dose administration.
Hepatic Impairment
Apraglutide
Phase 1
A two stage design, open label, multi-center, non-randomized trial to evaluate the the safety and tolerability of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of hepatic function. The hepatic function will estimated with the Child-Pugh classification. Part 1: 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects with normal hepatic function (Cohort 2). Part 2: 8 subjects with mild hepatic impairment (Cohort 3) and 8 subjects with normal hepatic function (from Cohort 2 where possible and additional subject). Part 2 will be conducted only if the geometric mean ratio (GMR) of AUCinf or AUClast for the moderate hepatic impairment group compared to the control group is ≥2.}}
Study Type : | Interventional |
Estimated Enrollment : | 16 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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 |
Actual Study Start Date : | January 30, 2023 |
Estimated Primary Completion Date : | April 4, 2023 |
Estimated Study Completion Date : | April 4, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Moderate hepatic impairment Child-Pugh B |
Drug: Apraglutide |
Experimental: Normal hepatic function Child-Pugh A |
Drug: Apraglutide |
Experimental: Mild hepatic impairment |
Drug: Apraglutide |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
APEX
Münich, Germany,
Not yet recruiting
Summit Clinical Research
Bratislava, Slovakia,