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Completed

NCT Number: NCT06268145

ECC5004 RBA FE Study in Healthy Participants

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eccogene Investigational Site

Anaheim, California, 92801, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECC5004

Drug

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

Primary outcomes

  1. 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

  2. ECC5004 PK parameters: AUC0-inf

    Time frame: Up to day 6

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

  3. ECC5004 PK parameters: Cmax

    Time frame: Up to day 6

    Maximum observed plasma concentration

  4. ECC5004 PK parameters: tmax

    Time frame: Up to day 6

    Time of the maximum observed plasma concentration

Secondary outcomes

  1. Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations

    Time frame: Up to Day 6

    Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.

  2. ECC5004 PK parameters: AUC0-tau

    Time frame: Up to day 6

    Area under the Plasma Concentration-Time Curve during the Dosing Interval

  3. ECC5004 PK parameters: AUC 0-24

    Time frame: Up to day 6

    Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose

  4. ECC5004 PK parameters: tlag

    Time frame: Up to day 6

    Lag time (time delay between dosing and first observed plasma concentration)

  5. ECC5004 PK parameters: t1/2

    Time frame: Up to day 6

    Apparent terminal elimination half-life

  6. ECC5004 PK parameters: CL/F

    Time frame: Up to day 6

    Apparent Clearance

  7. ECC5004 PK parameters: AUC(extr)

    Time frame: Up to day 6

    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

Sponsors and collaborators

Lead sponsor

Eccogene

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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