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Assessing the Pharmacokinetics Effects of Food on ASK120067 in Single Oral Administration in Chinese Healthy Subjects

NCT04360915 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-04-29

No results posted yet for this study

Summary

To evaluate the pharmacokinetic characteristics of ASK120067 and CCB4580030 after the single oral administration of ASK120067 in fast and after a high-fat meal in healthy Chinese subjects, and to evaluate the effect of food on the bioavailability of ASK120067.To evaluate the safety of ASK120067 tablets administered orally in fast and fed.

Conditions

  • Locally Advanced or Metastatic NSCLC

Interventions

DRUG

ASK120067

Take ASK120067 tablets orally in first day at 160 mg in fast condition.

DIETARY_SUPPLEMENT

ASK120067 in fed condition

Take ASK120067 tablets orally in first day at 160 mg in fed condition.

Sponsors & Collaborators

  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zourong Ruan · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2019-12-30
Completion
2019-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360915 on ClinicalTrials.gov