Clinical trial NCT06057103: A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects
Official title: A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects -a Single-center, Open-labelled, Six-sequence, Three-cycle Crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction
Lead sponsor: Nanjing Zenshine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary object of this study is evaluating the effect of multiple oral oseltamivir phosphate capsules on the pharmacokinetic profile of the active metabolite ZX-7101 after a single oral administration of ZX-7101A tablet in healthy Chinese adult subjects.

The seongdary object is evaluating combined or uncombined multiple oral oseltamivir phosphate in healthy Chinese adult subjects.


Eligibility criteria: Inclusion Criteria:

Healthy male or female subjects between the ages of 18 and 45 years (including the threshold value, based on the date of signing ICF).

Weight: Male weight ≥50 kg, female weight ≥45 kg, BMI between 19.0 and 28.0 kg/m2 (including cut-off value), BMI= weight (kg)/height 2 (m2).

The investigator judged the subjects to be in good overall health based on their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (routine blood work, urine work, blood biochemistry, coagulation function), viral serology, and chest X-ray results (normal or abnormal test results have no clinical significance).

Fertile female subjects or male subjects who voluntarily signed ICF should be no fertile, sperm/egg donation for 6 months (female) or 90 days (male) from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).

Fully understand the trial content and possible adverse reactions, have the ability to communicate with researchers normally, while complying with study requirements, follow protocol procedures and restrictions, and be able to visit on time.

Exclusion Criteria:

Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.

Subjects with digestive tract disease or any condition that may affect drug absorption, such as a history of liver and gallbladder disease, gastrointestinal disease, gastrointestinal surgery (except appendectomy) or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.

Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.

Acute respiratory infections within 2 weeks before screening; Or have a history of fungal infection.

For patients with abnormal vital signs (blood pressure, pulse rate, ear temperature) and clinically significant results, the abnormal values of each vital sign are:Body temperature (ear temperature) \>37.5 ℃; Systolic blood pressure (recumbent) \<90 mmHg or ≥140 mmHg; Diastolic blood pressure (lying) \<50 mmHg or ≥90 mmHg; Pulse rate (lying position) \<50 beats/min or \>100 beats/min.

QTcF interval \> 450ms or \< 300 ms (Fridericia's correction), or QRS\>120ms. Abnormal liver function: alanyl aminotransferase (ALT) or aspartate aminotransferase (AST) higher than the upper limit of normal or serum total bilirubin (TBIL) greater than 1.5 times the upper limit of normal, who judged clinical significance by investigators.

Subjects estimate glomerular filtration rate \<90 mL/min/1.73 m2. Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.

Subjects with a history of drug abuse (morphine, dimethylene dioxyamphetamine, methamphetamine, THC, ketamine, cocaine) or who screened positive for drug abuse.

Women who are pregnant or breastfeeding, or who test positive for blood pregnancy.

Subjects who have used any P-gp or CYP inducer or inhibitor within 30 days before screening, or any prescription or Chinese herbal medicine within 4 weeks before the start of the trial, or over-the-counter or health care products (including polyvalent cations and metal supplements, etc.) within 2 weeks before the start of the trial; It should have a longer time interval if the elimination half-life is longer-at least 5 elimination half-lives for the drug.

Primary outcomes:
measure: PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
timeFrame: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
measure: PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
timeFrame: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
measure: PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
timeFrame: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: