ECC5004 RBA FE Study in Healthy Participants

Eccogene

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ECC5004

Study type: Interventional

Funder types: Industry

Identifiers

NCT06268145

EC0006

Details and patient eligibility

About

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

Full 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

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Fixed Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: ECC5004

Fixed Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: ECC5004