Who is sponsoring NCT03596567?

NCT03596567 is sponsored by Pfizer.

What drugs are being tested in NCT03596567?

Interventions in NCT03596567: Glasdegib single 100 mg dose in normal healthy subjects, Glasdegib single 100 mg dose in moderate renal impairment subjects, Glasdegib single 100 mg dose in severe renal impairment subjects.

What condition does NCT03596567 study?

NCT03596567 studies Renal Impairment.

Is NCT03596567 still recruiting?

NCT03596567 is currently completed. Last updated 29 August 2019.

Last reviewed 2019-08-29 · How we verify

NCT03596567

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

Glasdegib Renal Impairment Study

Completed Phase 1 Last updated 29 August 2019

What this trial tests

Phase 1 trial testing Glasdegib single 100 mg dose in normal healthy subjects in Renal Impairment in 18 participants. Completed in 19 September 2018.

Timeline

17 May 2018

Primary endpoint
28 August 2018

19 September 2018

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	18
Start date	17 May 2018
Primary completion	28 August 2018
Estimated completion	19 September 2018
Sites	3 locations across United States

Drugs / interventions tested

Glasdegib single 100 mg dose in normal healthy subjects — full drug profile →
Glasdegib single 100 mg dose in moderate renal impairment subjects — full drug profile →
Glasdegib single 100 mg dose in severe renal impairment subjects — full drug profile →

Conditions studied

Renal Impairment — all drugs for Renal Impairment →

Sponsor

Pfizer — full company profile →

Who can join

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

Sponsor's own description

The goal of this study is to administer single dose (100 mg) glasdegib tablet to subjects with normal, moderate and severe renal impairment and estimate the effect, if any, of this renal impairment on glasdegib pharmacokinetics.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Hedgehog Signaling Pathway in Fibrosis and Targeted Therapies.
Hu Y, Peng L, Zhuo X, Yang C, et al · · 2024 · cited 6× · PMID 39766192 · DOI 10.3390/biom14121485
Evaluation of the impact of renal impairment on the pharmacokinetics of glasdegib in otherwise healthy volunteers.
Shaik N, LaBadie RR, Hee B, Chan G. · · 2021 · cited 5× · PMID 33388951 · DOI 10.1007/s00280-020-04207-9
Evaluation of the Relationship of Glasdegib Exposure and Safety End Points in Patients With Refractory Solid Tumors and Hematologic Malignancies.
Ruiz-Garcia A, Shaik N, Lin S, Jamieson C, et al · · 2021 · cited 3× · PMID 32974950 · DOI 10.1002/jcph.1742

Verify or expand the search:

Other recruiting trials for Renal Impairment

Currently open trials in the same condition.

NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · 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 NCT03596567 (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 Pfizer
Last refreshed: 29 August 2019

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/NCT03596567.

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