An Open-Label, Randomized, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Current Tablet Formulation (F1) Compared to New Tablet Formulation (F2) of ECC5004 and Food Effects on F1 and F2 of ECC5004 in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- ECC5004 PK parameters: AUC0-tlast
Study Overview
Brief Summary
This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants
Detailed Description
Eligible participants will be randomized to one of the two fixed treatment sequences with four treatment periods. In the first two treatment periods under fasted conditions, participants will fast for a minimum of 10 hours, then they will receive a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2. In the subsequent third and fourth treatment periods under fed conditions, participants will consume completely a high fat breakfast followed by administration of a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female participants of non-childbearing potential
- •Age of 18 to 65 years
- •BMI of 18.0 to 32.0 kg/m2
- •Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence
- •Male participants agree to use contraception, or agree to practice true abstinence
- •No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history
- •Able to understand and sign and date informed consent
Exclusion Criteria
- •Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study.
- •Concomitant participation in any investigational study of any nature
- •Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing
- •Serum calcitonin > 20 ng/L
- •Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems
- •Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC
- •History of pancreatitis
- •Significant allergic reaction to active ingredients or excipients of the study drug
- •Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.
Arms & Interventions
Fixed Sequence 1
Participants will receive single dose of ECC5004 F1 at fasted state, followed by F2 at fasted state, F1 at fed state and F2 at fed state in four treatment periods.
Intervention: ECC5004 (Drug)
Fixed Sequence 2
Participants will receive a single dose of ECC5004 F2 at fasted state, followed by F1 at fasted state, F2 at fed state, and F1 at fed state with four treatment periods.
Intervention: ECC5004 (Drug)
Outcomes
Primary Outcomes
ECC5004 PK parameters: AUC0-tlast
Time Frame: Up to day 6
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration
ECC5004 PK parameters: tmax
Time Frame: Up to day 6
Time of the maximum observed plasma concentration
ECC5004 PK parameters: AUC0-inf
Time Frame: Up to day 6
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
ECC5004 PK parameters: Cmax
Time Frame: Up to day 6
Maximum observed plasma concentration
Secondary Outcomes
- Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations(Up to Day 6)
- ECC5004 PK parameters: tlag(Up to day 6)
- ECC5004 PK parameters: AUC 0-24(Up to day 6)
- ECC5004 PK parameters: t1/2(Up to day 6)
- ECC5004 PK parameters: CL/F(Up to day 6)
- ECC5004 PK parameters: AUC(extr)(Up to day 6)
- ECC5004 PK parameters: AUC0-tau(Up to day 6)