ECC5004 RBA FE Study in Healthy Participants

NCT06268145 | Completed Phase 1 FDA Drug

• 1 other identifier: EC0006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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

• ECC5004 PK parameters: AUC0-inf

  Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity

  Up to day 6

• ECC5004 PK parameters: Cmax

  Maximum observed plasma concentration

  Up to day 6

• ECC5004 PK parameters: tmax

  Time of the maximum observed plasma concentration

  Up to day 6

Secondary Outcomes (7)

• 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: AUC0-tau

  Up to day 6

• ECC5004 PK parameters: AUC 0-24

  Up to day 6

• ECC5004 PK parameters: tlag

  Up to day 6

• ECC5004 PK parameters: t1/2

  Up to day 6

Study Arms (2)

Fixed Sequence 1

EXPERIMENTAL

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.

Drug: ECC5004

Fixed Sequence 2

EXPERIMENTAL

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.

Drug: ECC5004

Interventions

ECC5004 DRUG

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

Fixed Sequence 1; Fixed Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (1)

Eccogene Investigational Site

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eccogene

  Eccogene Clinical Trials

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: February 6, 2024
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)