A Phase 1 Oral Mass Balance and Combined Intravenous [ ¹⁴ C] Microtracer Study to Characterize the Absorption, Metabolism, Excretion, and Pharmacokinetics of Antitumor Drug E7386 in Humans

Shriram M. Pathak; Nozomi Hayata; Takashi Ueno; Jagadeesh Aluri; Jincao Wu; Ashley S. Brooks; Catherine M. Laing; Lea Dutta; Sanae Yasuda

doi:10.1002/jcph.70202

May 1, 2026The Journal of Clinical PharmacologyOpen Access

A Phase 1 Oral Mass Balance and Combined Intravenous [ ¹⁴ C] Microtracer Study to Characterize the Absorption, Metabolism, Excretion, and Pharmacokinetics of Antitumor Drug E7386 in Humans

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Key Points

This research aims to characterize the absorption, metabolism, excretion, and pharmacokinetics of the antitumor drug E7386 in humans.
Oral and intravenous (IV) administration of E7386 was tested in healthy participants.
Phase 1 study design focusing on mass balance and metabolism tracking through microtracers.
Assessment of tolerability and adverse events following drug administration.
E7386-related material is primarily excreted in feces post oral administration.
IV and oral dosing of E7386 was well-tolerated with manageable adverse events.

Implication

Phase 1 trial characterizes E7386 metabolism and excretion in healthy participants, indicating its tolerability.

Abstract

C]E7386-related material is predominantly excreted in feces after oral administration. Overall, IV administration and oral administration of a single E7386 dose was tolerable in healthy participants, and adverse events were manageable.

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Cite This Study

Pathak et al. (2026) studied this question.

synapsesocial.com/papers/6a0809d7a487c87a6a40baab https://doi.org/10.1002/jcph.70202

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A Phase 1 Oral Mass Balance and Combined Intravenous [ ¹⁴ C] Microtracer Study to Characterize the Absorption, Metabolism, Excretion, and Pharmacokinetics of Antitumor Drug E7386 in Humans

Key Points

Implication

Abstract

Discussion

Cite This Study

A Phase 1 Oral Mass Balance and Combined Intravenous [ ¹⁴ C] Microtracer Study to Characterize the Absorption, Metabolism, Excretion, and Pharmacokinetics of Antitumor Drug E7386 in Humans

Key Points

Implication

Abstract

Discussion

Cite This Study

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