Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

ClinicalTrials.gov ID: NCT02624557

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Official title

A Phase 1, Open-label, Single-dose, Multicenter, Parallel Group Study to Assess the Pharmacokinetics and Safety of Alpelisib (BYL719) in Subjects With Hepatic Impairment Compared to Matched Healthy Control Subjects.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.

Study identification

NCT ID: NCT02624557
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 23 participants

Conditions and interventions

Conditions

Hepatic Impairment

Interventions

Alpelisib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 21, 2015 (Actual)
Primary completion: Oct 1, 2017 (Actual)
Completion: Oct 1, 2017 (Actual)
Last update posted: Dec 9, 2020

2015 – 2017

United States locations

U.S. sites: 4
U.S. states: 3
U.S. cities: 4

Facility	City	State	ZIP	Site status
DaVita Clinical Research-Denver	Lakewood	Colorado	80228	—
University of Miami / Clinical Research Services, Inc.	Miami	Florida	33136	—
Orlando Clinical Research Center	Orlando	Florida	32809	—
DaVita Clinical Research	Minneapolis	Minnesota	55404	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02624557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 9, 2020 · Synced Nov 12, 2026