Actively Recruiting
ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants
Led by Eccogene · Updated on 2026-01-16
72
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I, open-label, randomized, single-dose, 2-part study designed to evaluate the food effect and relative bioavailability of ECC4703 in healthy adult participants.
CONDITIONS
Official Title
ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female participants
- Age of 18 to 65 years
- BMI of 18.0 to 32.0 kg/m2 with a minimum body weight of 50.0 kg (110 lb) for males and 45.0 kg (99 lb) for females
- Female participants of childbearing potential must have negative pregnancy tests at screening and before first dose, use at least one highly effective contraception method during the study and for 90 days after last dose, and avoid egg donation or fertility treatments during this period
- Female participants who are postmenopausal, surgically sterile, or agree to true abstinence
- Male participants agree to use contraception or true abstinence
- Not taking any interfering medications within 14 days or at least 5 half-lives prior to dosing, except stable contraception, stable hormonal replacement therapy, or paracetamol up to 2 g/day
- No clinically significant findings in physical exam, ECG, vital signs, labs, medications, or medical/psychiatric history
- Able to understand and provide informed consent
You will not qualify if you...
- Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 90 days after
- Participation in any other investigational study
- Blood loss of 470 mL or more for non-physiological reasons within 3 months before dosing, or plasma donation within 2 weeks, platelet donation within 6 weeks, or plans to donate blood during or one month after study
- Clinically relevant acute or chronic diseases affecting cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune, or dermatologic systems
- Significant allergic reactions to study drug ingredients
- Regular use of tobacco or nicotine products more than 5 times per week or quitting within past 2 months
- Unwillingness to abstain from alcohol and caffeine-containing products within 48 hours before admission
- Unwillingness to avoid grapefruit, grapefruit juice, and Seville oranges from 7 days before admission until after final follow-up
- Inability to avoid any medications, supplements, or herbal medicines during the study except allowed exceptions
- Any abnormal physical exam, lab, pregnancy, urine drug, alcohol test, or medical history findings preventing participation
- Clinically significant interventional therapies or hospitalization within 6 months prior or planned surgeries during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
E
Eccogene Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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