A Phase 1 interventional study of Obicetrapib in Hepatic Impairment and Healthy, sponsored by NewAmsterdam Pharma. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by NewAmsterdam Pharma · Phase 1, Interventional, and Other
To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg).
This is a Phase 1, open-label, single-dose, parallel-group study to evaluate the plasma PK and safety of obicetrapib in participants with moderate hepatic impairment relative to participants with normal hepatic function. The purpose of the study is to investigate the effect of moderate hepatic impairment on obicetrapib PK and safety in otherwise healthy participants after a single oral 10 mg dose of obicetrapib.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →NewAmsterdam Pharma is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
8 patients with hepatic impairment of moderate Child Pugh Category
Drug: Obicetrapib
Healthy volunteers will be matched with impaired hepatic function patients
Drug: Obicetrapib
1 single dose of obicetrapib
Also known as: 10 mg tablet
Area under the curve from dosing time to infinity (AUC (0-inf)) for obicetrapib
Blood samples collected
Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Area under curve from dosing time to last measurement (AUC (0-t)) for obicetrapib
Blood Sample Collected
Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Observed maximum plasma concentration (Cmax) for Obicetrapib
Blood Sample Collected
Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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NewAmsterdam Pharma