Evaluation of the impact of renal impairment on the pharmacokinetics of glasdegib in otherwise healthy volunteers.

ABSTRACT:

Purpose

Glasdegib is being developed for indications in myeloid malignancies. The effect of renal impairment on the pharmacokinetics (PK) of a single, oral, 100-mg glasdegib dose under fasted conditions was assessed.

Methods

Open-label, parallel-group study (NCT03596567). Participants of good general health were selected and categorized, based on their estimated glomerular filtration rate, into normal (≥ 90 mL/min), moderate (≥ 30 to < 60 mL/min), or severe (< 30 mL/min) renal impairment groups. Blood samples were collected up to 120 h post-dose. PK exposure parameters were calculated using non-compartmental analysis.

Results

All 18 participants completed the study. Respectively, ratios of adjusted geometric means (90% confidence interval) for glasdegib area under the

SUBMITTER: Shaik N 

PROVIDER: S-EPMC7870595 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature