NCT02624557 is a Phase 1 clinical trial of Alpelisib in Hepatic Impairment, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT02624557?

NCT02624557 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT02624557?

Interventions in NCT02624557: Alpelisib.

What condition does NCT02624557 study?

NCT02624557 studies Hepatic Impairment.

Is NCT02624557 still recruiting?

NCT02624557 is currently completed. Last updated 9 December 2020.

Last reviewed 2020-12-09 · How we verify

NCT02624557

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

Completed Phase 1 Last updated 9 December 2020

What this trial tests

Phase 1 trial testing Alpelisib in Hepatic Impairment in 23 participants. Completed in 1 October 2017.

Timeline

21 December 2015

Primary endpoint
1 October 2017

1 October 2017

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	23
Start date	21 December 2015
Primary completion	1 October 2017
Estimated completion	1 October 2017
Sites	4 locations across United States

Drugs / interventions tested

Alpelisib (alpelisib) — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacokinetics and Safety of Multiple-Dose Alpelisib in Participants with Moderate or Severe Hepatic Impairment: A Phase 1, Open-Label, Parallel Group Study.
Marbury T, El-Hashimy M, Blumenstein L, Letellier F, et al · · 2023 · cited 2× · PMID 37325049 · DOI 10.7150/jca.82736

Verify or expand the search:

Other trials of Alpelisib

Trials testing the same drug.

NCT06997588 — EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediat · Phase 2 · recruiting
NCT05948943 — Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. · Phase 2, PHASE3 · recruiting
NCT05967286 — Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial · Phase 2 · withdrawn
NCT04967248 — A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced o · terminated
NCT05646862 — A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Pa · Phase 3 · active not recruiting

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02624557 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 9 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02624557.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing