A Food Effect Study of QLS1410 in Healthy Chinese Adults

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Uncontrolled Hypertension

Treatments: Drug: QLS1410

Study type: Interventional

Funder types: Industry

Identifiers

NCT07358858

QSL1410-102

Details and patient eligibility

About

This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.

Full description

All the qualified participants will be randomized (1:1) to two treatment sequences (fed/fasting and fasting/fed). In each period, participants will receive a single dosing of QLS1410 tablets either with or without a high-fat breakfast. There will be a one-week washout period in this study.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).
2. Males and females aged 18 to 55 years, inclusive.
3. Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m^2, inclusive, at screening.
4. Has a mean seated office systolic blood pressure (SBP) 110~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).
5. QTcF (QT corrected using Fridericia's formula) <450 ms for males and <470 ms for females.
6. Participants (including partners) must agree to abstain from sperm/egg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.

Exclusion criteria

1. Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the cardiovascular, respiratory, digestive, urinary, endocrine metabolic, skeletal, muscular, hematologic, immune, nervous system.
2. Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
3. Use of systemic corticosteroids within 3 months prior to screening.
4. Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.
5. Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.
6. Mean pulse >100 or <50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
7. Any of the following laboratory abnormalities at screening: ALT or AST >1.5 x upper limit of normal (ULN); Total bilirubin >1.5 x ULN (participants with Gilbert's syndrome may qualify if direct bilirubin ≤ULN); Creatinine >ULN or eGFR <90 mL/min/1.73 m²; Serum potassium >ULN or sodium <135 mmol/L.
8. Smoking >5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
9. Alcohol consumption >14 units/week (1 unit = 357 mL of 3.5% beer, 27 mL of 40% spirits, or 104 mL of 12% wine) within 6 months before screening, or has a positive breath alcohol test at screening.
10. Blood donation >400 mL within 3 months or >200 mL within 4 weeks before screening, or plan to donate blood during the study.
11. Use of strong CYP3A4 or CYP1A2 inhibitors within 7 days or 5 half-lives (whichever is longer) before screening. Use of strong CYP3A4 inducer within 14 days or 5 half-lives (whichever is longer) before screening.
12. Use of any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks or 5 half-lives (whichever is longer) prior to randomization.
13. Pregnant/lactating females or positive pregnancy test at screening.
14. Inability to tolerate a high-fat meal.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

QLS1410 20mg

Experimental group

Treatment:

Drug: QLS1410