A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers

Phase 1 Completed 30 enrolled Sumitomo Pharma America, Inc.

NaSingle-groupOpen-labelTreatment

Summary

This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.

Timeline

Start: 2017-06-30
Primary completion: 2018-01-23
Completion: 2018-01-23

Publications

Dai X, Karol MD, Hitron M, Hard ML, Goulet MT, McLaughlin CF, Brantley SJ. Napabucasin Drug-Drug Interaction Potential, Safety, Tolerability, and Pharmacokinetics Following Oral Dosing in Healthy Adult Volunteers. Clin Pharmacol Drug Dev. 2021 Aug;10(8):824-839. doi: 10.1002/cpdd.961. Epub 2021 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Napabucasin	Small molecule	240 mg	—

Indications

No indication recorded.