A Food-Effect Study of CX11 in Healthy Participants

Official title

An Open-label, Randomized, Multiple-dose, Two-cycle, Two-way Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of CX11 Tablets in Healthy Participants

Overview

This study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants

Interventions

• Drug CX11 (VCT220)
  CX11 (VCT220) administered orally to participants who are in fasted/fed state in the first 6 consecutive days, and in fed/fasted state on the 7th day

Primary outcome measures

• Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220) [Time frame: Predose at Day1 up to 35 days postdose]
• Maximum Observed Concentration (Cmax) of CX11 (VCT220) [Time frame: Predose at Day1 up to 35 days postdose]
• Time to Maximum Observed Concentration (Tmax) of CX11 (VCT220) [Time frame: Predose at Day 1 up to 35 days postdose]

Eligibility criteria

Inclusion criteria

• Fully understand the objective, nature, methods, and possible adverse reactions of the study; be able to communicate well with the investigator; voluntarily take part in the study and be willing to comply with the requirements of this study; and sign the informed consent form before all study procedures are started
• Weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) is ≥ 20.0 kg/m2 and < 28 kg/m2 at the screening visit and on Day 21.

Exclusion criteria

• Participants with allergic constitution or known previous history of allergy to CX11 or similar compounds and related excipients, or history of atopic allergic diseases
• Participants who have experienced clinically significant acute diseases during the pre-study screening period or within 2 weeks prior to the first dose of the investigational product
• Participants who have pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could affect drug absorption, distribution, metabolism, and/or excretion as judged by the investigator, or plan to receive any surgery during the study
• Participants suffering from any clinically significant chronic diseases, including but not limited to disorders of the respiratory system, cardiovascular system, urinary system, blood system, endocrine system, and immune system, as well as the digestive system (e.g., history of or current fatty liver disease, including metabolic dysfunction-associated steatohepatitis
• History of thyroid dysfunction requiring medication or with a thyroid stimulating hormone (TSH) level exceeding the normal reference range at screening or on Day 21
• Participants who have been vaccinated within 30 days before the screening or plan to be vaccinated during the study
• Participated in any other clinical study and received an investigational intervention within 90 days or 5 elimination half-lives (whichever is longer) of the investigational intervention, prior to screening

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Basic science

Study locations

China · 1 center

• Shanghai Xuhui Central Hospital — Shanghai

Identifiers

NCT: NCT07349381 · CX11101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗