AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 1NCT06268145

ECC5004 RBA FE Study in Healthy Participants

A Phase 1 study testing ECC5004 in people with Type 2 Diabetes Mellitus, run by Eccogene at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
ECC5004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
6 Feb 2024to 29 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Eccogene Investigational Site

    Anaheim, California, 92801

Other trials in United States

About this study

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

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

Read the detailed 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

Being tested
ECC5004
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECC5004Drug

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

Study groups in NCT06268145
Study groupRoleWhat they receive
Fixed Sequence 1ExperimentalParticipants 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.
Receives: Drug: ECC5004
Fixed Sequence 2ExperimentalParticipants 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.
Receives: Drug: ECC5004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ECC5004 PK parameters: AUC0-tlast

    Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration

    Measured: Up to day 6

  2. ECC5004 PK parameters: AUC0-inf

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

    Measured: Up to day 6

  3. ECC5004 PK parameters: Cmax

    Maximum observed plasma concentration

    Measured: Up to day 6

  4. ECC5004 PK parameters: tmax

    Time of the maximum observed plasma concentration

    Measured: Up to day 6

Secondary outcomes (7)

  1. 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.

    Measured: Up to Day 6

  2. ECC5004 PK parameters: AUC0-tau

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

    Measured: Up to day 6

  3. ECC5004 PK parameters: AUC 0-24

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

    Measured: Up to day 6

  4. ECC5004 PK parameters: tlag

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

    Measured: Up to day 6

  5. ECC5004 PK parameters: t1/2

    Apparent terminal elimination half-life

    Measured: Up to day 6

  6. ECC5004 PK parameters: CL/F

    Apparent Clearance

    Measured: Up to day 6

  7. 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

    Measured: Up to day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start6 Feb 2024
  3. Primary completion29 Mar 2024
  4. Study completion29 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06268145
Sponsor's protocol ID
EC0006
Status last verified
Jul 2024
First submitted
13 Feb 2024
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu J, Haggag A, Butcher L, Liu H, Chen W, Sun X, Jha A, Yu H, Khan A, Parker VER, Tannergren C, Pan X, Xu J, Zhou J. Phase 1, open-label, randomized study of the elecoglipron pharmacokinetic profile in healthy participants under fed and fasted conditions. Br J Clin Pharmacol. 2026 Oct 19. doi: 10.1002/bcp.70852. Online ahead of print.

    PubMed 42896872

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ECC5004 in people with Type 2 Diabetes Mellitus, run by Eccogene at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ECC5004 PK parameters: AUC0-tlast (time frame: Up to day 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06268145, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in