ECC5004 RBA FE Study in Healthy Participants

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268145
• Other study ID #: EC0006
• Status: Recruiting
• Phase: Phase 1
• Start date: February 6, 2024
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2024
• Source: Eccogene
• Contact: Eccogene Clinical Trials
• Phone: 86-21-61053022
• Email: contact[@]eccogene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ECC5004
A single dose tablet of 50 mg of the current tablet formulation (F1) or new tablet formulation (F2) administered orally.

Locations

Country	Name	City	State
United States	Eccogene Investigational Site	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Eccogene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECC5004 PK parameters: AUC0-tlast	Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration	Up to day 6
Primary	ECC5004 PK parameters: AUC0-inf	Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity	Up to day 6
Primary	ECC5004 PK parameters: Cmax	Maximum observed plasma concentration	Up to day 6
Primary	ECC5004 PK parameters: tmax	Time of the maximum observed plasma concentration	Up to day 6
Secondary	Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations	Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.	Up to Day 6
Secondary	ECC5004 PK parameters: AUC0-tau	Area under the Plasma Concentration-Time Curve during the Dosing Interval	Up to day 6
Secondary	ECC5004 PK parameters: AUC 0-24	Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose	Up to day 6
Secondary	ECC5004 PK parameters: tlag	Lag time (time delay between dosing and first observed plasma concentration)	Up to day 6
Secondary	ECC5004 PK parameters: t1/2	Apparent terminal elimination half-life	Up to day 6
Secondary	ECC5004 PK parameters: CL/F	Apparent Clearance	Up to day 6
Secondary	ECC5004 PK parameters: AUC(extr)	Area under the curve from the first measured concentration value back extrapolated to the concentration value at time zero as a percentage of the area under the curve extrapolated to infinity using the predicted value of the last non-zero concentration	Up to day 6