How food affects DA-5223 levels in healthy adults
An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
We will see if taking DA-5223 with food changes how much and how quickly the drug appears in the blood of healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | All |
| Sponsor | Dong-A ST Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT07007520 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study gives DA-5223 to healthy adult volunteers under both fed and fasting conditions and measures blood drug concentrations over time. Participants receive the drug in each condition and undergo serial blood sampling to determine pharmacokinetic parameters such as peak concentration and overall exposure. The within-subject comparison shows whether a meal alters absorption, distribution, or clearance of DA-5223. Findings will guide how the drug should be taken in later patient studies and labeling.
Who should consider this trial
Good fit: Healthy adults aged 19–55 with BMI 18.0–30.0 kg/m2 and minimum weights of 50 kg for males and 45 kg for females who can give informed consent.
Not a fit: People who are acutely ill, pregnant or lactating, have gastrointestinal disease or prior surgeries affecting absorption, or who cannot abstain from smoking, alcohol, or caffeine during hospitalization are excluded and unlikely to benefit from this study.
Why it matters
Potential benefit: If a food effect is found, results can be used to recommend whether DA-5223 should be taken with or without food so patients receive the intended drug exposure.
How similar studies have performed: Food-effect pharmacokinetic comparisons are a routine, well-established step in drug development and have reliably guided dosing for many medicines.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult male or female, 19 years to 55 years * Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 * The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate Exclusion Criteria: * The subjects with acute illness * The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product * The subjects hypersensitive to any of the Investigational Product components or other drug components * The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization * The subjects who are pregnant or lactating
Where this trial is running
Seongnam-si, Gyeonggi-do
- CHA Global Clinical Trials Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Wonsuk Shin
- Email: wonsug89@chamc.co.kr
- Phone: 82-31-780-5346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.