Spots Global Cancer Trial Database for IMP4297 Food Effect Trial in Healthy Volunteers
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Trial Identification
Brief Title: IMP4297 Food Effect Trial in Healthy Volunteers
Official Title: An Open-label, Randomized, Single-dose, Two-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of IMP4297 Capsules in Healthy Subjects
Study ID: NCT04057729
Conditions
Interventions
Study Description
Brief 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
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: MALE
Healthy Volunteers: Yes
Locations
Shanghai Public Health Clinical Center, Shanghai, , China
Contact Details
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