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Fixed Sequence 2 for Type 2 Diabetes

Phase 1
Recruiting
Research Sponsored by Eccogene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male and female participants of non-childbearing potential
Age of 18 to 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 6
Awards & highlights

Study Summary

This trial will test whether a new version of a medication works the same as the current version when taken by healthy volunteers on an empty stomach and with food.

Who is the study for?
This trial is for healthy individuals who can participate in a study to compare two different tablet formulations of ECC5004, which may be used for Type 2 Diabetes. Participants should not have any health conditions that could interfere with the drug's effects or their ability to complete the study.Check my eligibility
What is being tested?
The trial is testing the absorption and effect of two formulations (F1 and F2) of a potential diabetes medication called ECC5004 when taken with or without food. It's an early-stage (Phase 1), open-label study where everyone knows what treatment they're getting, and it involves switching between treatments.See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on comparing bioavailability rather than therapeutic effects, specific side effects are not detailed here but generally could include digestive discomfort, allergic reactions, or other mild adverse events typical in early drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am healthy and cannot become pregnant or get someone pregnant.
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I am between 18 and 65 years old.
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I am a male and agree to use contraception or practice abstinence.
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My recent health checks and heart tests show no significant issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ECC5004 PK parameters: AUC0-inf
ECC5004 PK parameters: AUC0-tlast
ECC5004 PK parameters: Cmax
+1 more
Secondary outcome measures
ECC5004 PK parameters: AUC 0-24
ECC5004 PK parameters: AUC(extr)
ECC5004 PK parameters: AUC0-tau
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Fixed Sequence 2Experimental Treatment1 Intervention
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.
Group II: Fixed Sequence 1Experimental Treatment1 Intervention
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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

EccogeneLead Sponsor
3 Previous Clinical Trials
182 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently enrolled as participants in this clinical trial?

"Indeed, information on clinicaltrials.gov indicates that this particular research study is actively seeking eligible participants. The trial was initially disclosed on February 6th, 2024 and last revised on February 13th, 2024. Recruitment aims to find 14 suitable candidates from a single designated site."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The main focus of this clinical study, to be monitored for approximately up until day 6, is on ECC5004 PK parameters: tmax. Subsidiary objectives encompass ECC5004 PK parameters: AUC0-tau (Area under the Plasma Concentration-Time Curve during the Dosing Interval), evaluation of adverse events and anomalies in laboratory tests, ECG readings, vital signs as well as physical examinations - collectively referred to as Safety Assessment. Additionally, attention will be given to ECC5004 PK parameters such as AUC 0-24 (Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours"

Answered by AI

Are there any available slots for patients to participate in this research study?

"As per the details on clinicaltrials.gov, patient recruitment is ongoing for this trial. It was initially listed on February 6th, 2024, with the latest update reflecting February 13th of the same year."

Answered by AI

Does this study include individuals older than 35 years of age?

"Eligible candidates for this research endeavor must fall within the age bracket of 18 to 65 years. It is noteworthy that there are a total of 41 investigations aimed at individuals younger than 18 and another 739 studies designed for those over the age of 65."

Answered by AI

What are the associated risks of Fixed Sequence 1 for individuals?

"Based on our assessment at Power, Fixed Sequence 1 is given a safety rating of 1 due to the preliminary nature of this Phase 1 trial with limited data supporting its efficacy and safety profile."

Answered by AI

Who else is applying?

What site did they apply to?
Eccogene Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
ECC5004 RBA FE Study in Healthy Participants
2024. "ECC5004 RBA FE Study in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268145.
All > Los Angeles > Paid Studies Ventura
~9 spots leftby Apr 2025
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