Dataset Information

A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [¹⁴C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants.

ABSTRACT: Mobocertinib (TAK-788) is a first-in-class oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that received accelerated approval for the treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations previously treated with platinum-based chemotherapy. This phase 1, 2-period, study was conducted to assess the absolute bioavailability of mobocertinib (Period 1), as well as mass balance, pharmacokinetics, metabolism, and excretion of [¹⁴C]-mobocertinib (Period 2) in healthy adult males. In Period 1, participants received a single oral capsule dose of 160 mg mobocertinib, followed by a 15-minute intravenous infusion of 50 µg (~ 2 µCi) [¹⁴C]-mobocertinib administered from 3.75 to 4 h after the capsule dose. In Period 2, a s

SUBMITTER: Hanley MJ

PROVIDER: S-EPMC11327196 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Dataset Information

A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [¹⁴C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants.

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [14C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants.

OmicsDI is part of the ELIXIR infrastructure

Tweets

A phase 1 study to assess the absolute bioavailability, mass balance, pharmacokinetics, metabolism, and excretion of [¹⁴C]-mobocertinib, an oral inhibitor of EGFR exon 20 insertion mutations, in healthy participants.