NCT06268145CompletedPhase 1
ECC5004 RBA FE Study in Healthy Participants
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 13 Feb 2024
- Start date
- Feb 2024
- Primary completion date
- Mar 2024
- Lead sponsor
- Eccogene
- Diseases
- Type 2 diabetes
- NCT number
- NCT06268145
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- From Feb 2024 to the primary completion date, Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Serum calcitonin \> 20 ng/L
- 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.
Other
- Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
Related publications
- Phase 1, open-label, randomized study of the elecoglipron pharmacokinetic profile in healthy participants under fed and fasted conditions.Br J Clin Pharmacol · 2026 · PMID 42896872
This page is information, not medical advice. Discuss any trial with your doctor.