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Drug-drug Interaction Study Beteewn ASK120067 and Rifampicin or Itraconazole

NCT05631678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-11-30

No results posted yet for this study

Summary

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects.

To evaluate the safety of ASK120067 tablets or combination with rifampicin capsules or itraconazole capsules in healthy subjects.

Conditions

  • Locally Advanced or Metastatic NSCLC

Interventions

DRUG

Rifampicin; ASK120067

Take ASK120067 tablets orally once on the first day at 160mg in fast condition;Take rifampicin capsules orally once on the days 8 to 17 at 600mg in fast condition, and a combination of 160mg ASk120067 and 600mg rifampicin were administrated on the 15th day in fast condition.

DRUG

ASK120067;itraconazole

Take ASK120067 tablets orally once on the first day at 80mg in fast condition;Take itraconazole capsules orally twice on the days 8 to 13 at 200mg in fed condition, and a combination of 80mg ASK120067 and 200mg itraconazole were administrated on the 11th day in fast condition.

Sponsors & Collaborators

  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Juan Li · Drum Tower Hospital of Nanjing University School of Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-06
Primary Completion
2022-08-03
Completion
2022-08-03

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 NCT05631678 on ClinicalTrials.gov