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Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants

NCT06087055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-10-17

No results posted yet for this study

Summary

The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants.

Conditions

  • Healthy Participant

Interventions

DRUG

GST-HG171/Ritonavir

Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3

DRUG

Itraconazole

Administered orally once daily for 9 days from Days 8 through 16

DRUG

GST-HG171/Ritonavir

Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14

Sponsors & Collaborators

  • Fujian Akeylink Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2023-06-05
Completion
2023-08-07

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 NCT06087055 on ClinicalTrials.gov