Absorption, metabolism, and excretion of [¹⁴C]ponatinib after a single oral dose in humans.

ABSTRACT:

Purpose

Ponatinib is a novel tyrosine kinase inhibitor (TKI) specifically designed to inhibit native and mutated BCR-ABL. In the United States, ponatinib has received accelerated approval for adults with T315I-positive chronic myeloid leukemia (CML) or T315I (gatekeeper mutation)-positive, Philadelphia chromosome-positive, acute lymphoblastic leukemia (Ph + ALL), and patients with CML or Ph + ALL for whom no other TKI therapy is indicated. The objective of this phase 1, mass balance study was to evaluate the absorption, metabolism, and excretion of [¹⁴C]ponatinib in healthy subjects.

Methods

A single 45-mg [¹⁴C]ponatinib dose was administered orally to six healthy male volunteers, and absorption, metabolism, and excretion were assessed.

Results

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SUBMITTER: Ye YE 

PROVIDER: S-EPMC5344956 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature