Trial reportCancer chemotherapy and pharmacology2019
Evaluation of the effects of formulation, food, or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study.
Trial report in Cancer chemotherapy and pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03130556 (A Phase 1, Randomized, Open-label Study Of Glasdegib), which is not on this map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1, Randomized, Open-label Study Of Glasdegib (Pf-04449913) In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The Glasdegib Ich Formulation And To Estimate The Potential Effect Of Food And A Proton Pump Inhibitor On Glasdegib Plasma Pharmacokinetics
Who cites it
9 citing papers in PubMed, 19 citations in OpenAlex.
- Glasdegib plus low-dose cytarabine for acute myeloid leukemia: Practical considerations from advanced practitioners and pharmacists.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2021Trial
- Absolute Oral Bioavailability of Glasdegib (PF-04449913), a Smoothened Inhibitor, in Randomized Healthy Volunteers.Clinical pharmacology in drug development · 2019Trial
- Pharmacodynamics, pharmacokinetics, interactions with other drugs, toxicity and clinical effectiveness of proton pump inhibitors.Frontiers in pharmacology · 2025Review
- Exploring the Relationship of Drug BCS Classification, Food Effect, and Gastric pH-Dependent Drug Interactions.The AAPS journal · 2021Article
- Carboxylic Acid Counterions in FDA-Approved Pharmaceutical Salts.Pharmaceutical research · 2021Review
- Pharmacokinetics and Safety of Glasdegib in Participants With Moderate/Severe Hepatic Impairment: A Phase I, Single-Dose, Matched Case-Control Study.Clinical pharmacology in drug development · 2021Article
- Evaluation of the impact of renal impairment on the pharmacokinetics of glasdegib in otherwise healthy volunteers.Cancer chemotherapy and pharmacology · 2021Article
- Discovering Anti-Cancer DrugsFrontiers in pharmacology · 2020Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo demonstrate the bioequivalence of the planned maleate salt-based commercial glasdegib tablet formulation [International Council for Harmonization (ICH) glasdegib] to the clinical di-hydrochloride (di-HCl) salt-based glasdegib formulation (di-HCl glasdegib). Additionally, to estimate the effects of a high-fat, high-calorie meal and proton-pump inhibitor (PPI) on the pharmacokinetics of ICH glasdegib.
methodsThis Phase I open-label study (ClinicalTrials.gov: NCT03130556) enrolled 24 healthy subjects to receive two different tablet formulations of single-dose 100-mg glasdegib under fasted conditions. A subset of healthy volunteers (n = 12) received single-dose 100-mg ICH glasdegib following a high-fat, high-calorie meal or concurrently with a PPI (rabeprazole).
resultsThe adjusted geometric mean ratio (ICH glasdegib:di-HCl glasdegib) and 90% confidence intervals (CI) of area under the plasma concentration-time curve from time zero to infinity (AUC
conclusionsThe ICH glasdegib tablet formulation was bioequivalent to the clinical di-HCl formulation under fasted conditions. A high-fat, high-calorie meal or concurrent PPI treatment had a minimal effect on glasdegib exposure, and was not considered clinically meaningful.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.