Actively Recruiting
A Phase I, Open-Label, Randomized, Single-Dose, Crossover Study to Evaluate Food Effect and Relative Bioavailability of ECC4703 Formulations (F0, F1, F2, and F3) in Healthy Adults
Led by Eccogene · Updated on 2026-01-16
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of food on the absorption and availability of different ECC4703 drug formulations in healthy adults. This Phase I, open-label, randomized study aims to understand how food influences the drug's behavior in the body by comparing various formulations in single-dose treatments. The study involves healthy adults aged 18 to 65 years with no significant health conditions. The study has two parts. Part 1 involves three groups of 16 participants each who will receive single doses of ECC4703 formulations F1, F2, and F3 in both high-fat and fasted states to assess food effects. Part 2 will enroll about 24 participants to compare selected formulations from Part 1 with formulation F0, using an adaptive design to determine treatment sequences and conditions. Participants receive the drug in specific sequences to measure how food affects drug absorption. Participants will undergo assessments including physical exams, vital signs, ECGs, and laboratory tests to monitor health and drug effects. Researchers will measure pharmacokinetic parameters such as drug concentration over time, peak concentration, and elimination rates up to 13 days after dosing. Safety evaluations include monitoring adverse events and clinical tests up to 18 days. Participants' involvement includes multiple visits for dosing and follow-up assessments during the study period.
CONDITIONS
Brief 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
- Minimum body weight of 50.0 kg (110 lb) for males
- Minimum body weight of 45.0 kg (99 lb) for females
- Female participants of childbearing potential must have negative pregnancy tests before dosing
- Female participants must use at least one highly effective contraception method during the study and for 90 days after last dose
- Postmenopausal or surgically sterile females or those practicing true abstinence
- Male participants must agree to use contraception or practice true abstinence
- No medication use within 14 days prior to dosing except stable contraception, hormonal therapy, or paracetamol up to 2 g/day
- No clinically significant findings in exams, ECG, vitals, labs, or medical history
- Able to understand, sign, and date informed consent
You will not qualify if you...
- Females who are pregnant, planning pregnancy, or breastfeeding during or within 90 days after the study
- Participation in any other investigational study
- Blood loss ≥470 mL for non-physiological reasons within 3 months prior to dosing
- Plasma donation within 2 weeks prior to dosing
- Platelet donation within 6 weeks prior to dosing
- Plans to donate blood during or within 1 month after the study
- Clinically relevant acute or chronic medical conditions of major organ systems
- Significant allergic reactions to study drug ingredients
- Regular tobacco or nicotine use (>5 times per week) or recent cessation within 2 months
- Unwillingness to abstain from alcohol, caffeine, grapefruit, and related products as required
- Inability to refrain from medications or supplements during the study except allowed exceptions
- Any significant abnormal clinical or laboratory findings preventing study participation
- Recent significant interventional therapies or hospitalization within 6 months or planned surgeries during the study
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 - Up to 13 days
Participants receive single doses of different ECC4703 formulations under fasting and high-fat conditions in multiple treatment periods to assess food effect and relative bioavailability.
Multiple visits for dosing and assessments across 2 crossover periods
Duration - Up to 5 days after treatment (total study up to 18 days)
Participants are monitored for safety including adverse events, laboratory tests, vital signs, and physical examinations after dosing.
Visits for safety assessments up to Day 18
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
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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