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

An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole With GST-HG171/Ritonavir in Healthy Adult Chinese Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participant
• Intervention / Treatment: Drug: GST-HG171/Ritonavir; Drug: GST-HG171/Ritonavir; Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
2. Ability to complete research in accordance with test plan requirements;
3. Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
4. Male and female healthy subjects aged 18 to 50 years (including 18 and 50 years old);
5. 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);
6. Physical examination, normal or abnormal vital signs have no clinical significance.

Exclusion Criteria:

1. Allergies (multiple drugs and food allergies);
2. Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
3. 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);
4. Blood donation or massive blood loss (> 400 mL) within three months before screening;
5. 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;
6. Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
7. Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
8. 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;
9. 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;
10. Vaccinated within 14 days before screening or planned to be vaccinated during the study;
11. 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;
12. Abnormal ECG has clinical significance;
13. Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study;
14. 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;
15. Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody;
16. Acute disease or concomitant medication occurs from the screening stage to before study medication;
17. Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug;
18. People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years;
19. The investigator believes that there are other subjects who are not suitable for participating in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1; GST-HG171/ritonavir orally	Drug: GST-HG171/Ritonavir; Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3; Drug: GST-HG171/Ritonavir; Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14
Experimental: Period 2; Itraconazole+GST-HG171/ritonavir orally	Drug: GST-HG171/Ritonavir; Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3; Drug: GST-HG171/Ritonavir; Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14; Drug: Itraconazole; Administered orally once daily for 9 days from Days 8 through 16

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Screening up to Day 17

Collaborators and Investigators

• Sponsor: Fujian Akeylink Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; 14-alpha Demethylase Inhibitors; Ritonavir; Itraconazole
• Other Study ID Numbers: GST-HG171-I-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No