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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Jilin
-
Changchun, Jilin, China
- The First Hospital of Jilin University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Acute disease or concomitant medication occurs from the screening stage to before study medication;
- Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug;
- People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years;
- 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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Period 1
GST-HG171/ritonavir orally
|
Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
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
|
Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14
Administered orally once daily for 9 days from Days 8 through 16
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Observed Concentration (Cmax) of GST-HG171
Time Frame: 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.
|
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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AEs
Time Frame: Screening up to Day 17
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
Screening up to Day 17
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- GST-HG171-I-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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