Actively Recruiting
An Open-label, Randomized, Two-cycle, Two-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of CX11 Tablets in Healthy Adults
Led by Vincentage Pharma Co., Ltd · Updated on 2026-03-27
32
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
V
Vincentage Pharma Co., Ltd
Lead Sponsor
C
Corxel Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how food affects the way the body processes CX11 tablets in healthy adults aged 18 to 45. This Phase 1 study focuses on understanding the impact of food intake on the drug's absorption, concentration, and timing in the bloodstream. The study includes participants with a body mass index (BMI) between 20 and 28 who are otherwise healthy and meet specific weight requirements. Participants will receive CX11 orally over two cycles in a randomized, open-label, crossover design. One group will take the drug first while fasting then while fed, and the other group will follow the opposite order. Each cycle includes seven days of dosing with the drug given in different fed or fasted states to compare how food intake influences the drug’s pharmacokinetics. Throughout the study, participants will have blood samples taken to measure drug levels, including the area under the concentration-time curve (AUC), maximum concentration (Cmax), and time to maximum concentration (Tmax) over 35 days. Safety and adherence will be monitored, with the total participation lasting through the dosing and follow-up periods to assess how food affects the drug’s behavior in the body.
CONDITIONS
Brief Title
A Food-Effect Study of CX11 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and sign the informed consent form before starting
- Be willing to participate voluntarily and communicate well with the investigator
- Weigh at least 50 kg if male or 45 kg if female
- Have a body mass index (BMI) between 20 and 28 kg/m2 at screening and Day 21
You will not qualify if you...
- History of allergy to CX11 or related substances, or atopic allergic diseases
- Recent acute illness during screening or within 2 weeks before first dose
- Any gastrointestinal, liver, or kidney condition affecting drug processing, or planned surgery during the study
- Significant chronic diseases such as respiratory, cardiovascular, urinary, blood, endocrine, immune, or digestive disorders
- Thyroid dysfunction requiring medication or abnormal thyroid hormone levels at screening or Day 21
- Vaccinated within 30 days before screening or planning vaccination during the study
- Participation in another clinical trial with investigational drug within the past 90 days or 5 elimination half-lives, whichever is longer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 consecutive days per cycle across two cycles
Participants receive CX11 tablets orally in a fasted or fed state over two cycles with different food conditions to evaluate the effect of food on the drug's pharmacokinetics.
2 treatment cycles with daily dosing and pharmacokinetic assessments
Trial Site Locations
Total: 1 location
1
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
W
Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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