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IMP4297 Food Effect Trial in Healthy Volunteers

2019-08-20 20:17:11 | BioPortfolio

Summary

A phase I, single-site, open-label, randomized, single-dose, two-way crossover study to evaluate the effect of food on the pharmacokinetic characteristics of IMP4297 capsules in China

Description

This food-effect study plans to enroll 16 (at least 12 to complete the study) subjects. Subjects will be randomly assigned to 1 of 2 dosing sequences (fasted or standard high-fat breakfast) at a 1:1 ratio generated from a computer. Each dosing sequence will consist of 2 cycles, with 1 dose in each cycle of the study and a washout period of at least 7 days between each dose. Study drug will be administered to subjects in the morning of each administration day of each cycle. PK, ECG, vital signs, physical examinations and laboratory tests will be performed as specified in the protocol. Tolerability and safety of the treatment will be evaluated by monitoring adverse events.

Study Design

Conditions

Solid Tumor

Intervention

IMP4297

Location

Shanghai Public Health Clinical Center
Shanghai
China

Status

Recruiting

Source

Impact Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-20T20:17:11-0400

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