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

NCT06087055 | Completed Phase 1

• 1 other identifier: GST-HG171-I-04
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Maximum Observed Concentration (Cmax) of GST-HG171

  The Cmax of GST-HG171 in the study was observed directly from data.

  Days 2(pre-dose), 3 (pre-dose,0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24 and 48 hours postdose on Day 3) in Period 1; Days 13(pre-dose), Days 14 (pre-dose, 0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24,48, and 72 hours postdose on Day 14) of Period 2.

Secondary Outcomes (1)

• AEs

  Screening up to Day 17

Study Arms (2)

Period 1

EXPERIMENTAL

GST-HG171/ritonavir orally

Drug: GST-HG171/Ritonavir

Period 2

EXPERIMENTAL

Itraconazole+GST-HG171/ritonavir orally

Drug: Itraconazole; Drug: GST-HG171/Ritonavir

Interventions

GST-HG171/Ritonavir DRUG

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

Period 1

Itraconazole DRUG

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

Period 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
• Ability to complete research in accordance with test plan requirements;
• Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
• Male and female healthy subjects aged 18 to 50 years (including 18 and 50 years old);
• Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 \~ 28 kg / m2 (including critical value);
• Physical examination, normal or abnormal vital signs have no clinical significance.

You may not qualify if:

• Allergies (multiple drugs and food allergies);
• Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
• Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
• Blood donation or massive blood loss (\> 400 mL) within three months before screening;
• Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including a history of frequent nausea or vomiting caused by any cause;
• Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
• Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
• Have Intended to take any drug that changes the activity of drug metabolizing enzyme 28 days before screening or during the study, including strong inhibitors and inducers that affect the metabolizing enzyme;
• Took any prescription drugs or herbs within 14 days before screening, or took over-the-counter drugs or any vitamin products within 7 days before screening;
• Vaccinated within 14 days before screening or planned to be vaccinated during the study;
• Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening;
• Abnormal ECG has clinical significance;
• Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study;
• Clinical laboratory examinations are abnormal and clinically significant, or find the following diseases with clinical significance (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease) within 6 months before screening;
• Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody;

Sponsors & Collaborators

• Fujian Akeylink Biotechnology Co., Ltd.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Interventions

Ritonavir; Itraconazole

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: May 12, 2023
• Primary Completion: June 5, 2023
• Study Completion: August 7, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-05

Locations

CN (1)