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Midazolam, Atorvastatin, ECC5004 (Part B) 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part a and optional part c: up to day 16; part b and optional part d: up to day 40

Awards & highlights

Study Summary

"This trial is looking at how ECC5004 affects the levels of certain medications (Atorvastatin, Rosuvastatin, Digoxin, and Midazolam) in healthy participants

Who is the study for?

This trial is for healthy individuals, likely to assess if the new drug ECC5004 affects how the body processes other common medications like Atorvastatin, Rosuvastatin, Digoxin, and Midazolam.Check my eligibility

What is being tested?

The study is testing how a single dose of ECC5004 influences the pharmacokinetics (how drugs are absorbed, distributed, metabolized, and excreted) of four different medications when taken by healthy people.See study design

What are the potential side effects?

Since this information isn't provided directly in your summary above and it's a Phase 1 trial primarily focused on safety and dosage levels in healthy volunteers rather than efficacy or side effects in patients with specific conditions. Side effects could range from none to mild or moderate depending on individual reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part a and optional part c: up to day 16; part b and optional part d: up to day 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part a and optional part c: up to day 16; part b and optional part d: up to day 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and part a and optional part c: up to day 16; part b and optional part d: up to day 40 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Atorvastatin PK parameters: AUC(0-inf)

Atorvastatin PK parameters: AUC(0-tlast)

Atorvastatin PK parameters: Cmax

+9 more

Secondary outcome measures

Atorvastatin safety parameters: Number of participants with adverse events (AEs)

Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities

Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG)

+28 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Midazolam, Atorvastatin, ECC5004 (optional Part D)Experimental Treatment3 Interventions

Optional Part D consists of 5 treatment periods. In treatment period 1, participants will receive Midazolam administered alone followed by treatment period 2 in which participants will receive Atorvastatin administered alone. In treatment period 3, participants will receive ECC5004 alone. In treatment period 4, participants will receive ECC5004 in combination with Midazolam. In treatment period 5, ECC5004 will be administered alone and co-administered with Atorvastatin.

Group II: Midazolam, Atorvastatin, ECC5004 (Part B)Experimental Treatment3 Interventions

Part B consists of 5 treatment periods. In treatment period 1, participants will receive Midazolam administered alone followed by treatment period 2 in which participants will receive Atorvastatin administered alone. In treatment period 3, participants will receive ECC5004 alone. In treatment period 4, participants will receive ECC5004 in combination with Midazolam. In treatment period 5, ECC5004 will be administered alone and co-administered with Atorvastatin.

Group III: Digoxin, Rosuvastatin, ECC5004 (optional Part C)Experimental Treatment3 Interventions

Optional Part C consists of 2 treatment periods. Participants will receive Digoxin and Rosuvastatin administered alone in treatment period 1 and in combination with ECC5004 in treatment period 2.

Group IV: Digoxin, Rosuvastatin, ECC5004 (Part A)Experimental Treatment3 Interventions

Part A consists of 2 treatment periods. Participants will receive Digoxin and Rosuvastatin administered alone in treatment period 1 and in combination with ECC5004 in treatment period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atorvastatin

1998

Completed Phase 4

~10900

Midazolam

2018

Completed Phase 4

~1910

Rosuvastatin

2019

Completed Phase 4

~3150

Digoxin

2017

Completed Phase 4

~670

Do I qualify?Apply below to find out

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

132 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of subjects actively involved in this research investigation?

"Affirmative. Information retrieved from clinicaltrials.gov indicates that this particular medical study is actively seeking eligible participants. Originally posted on February 9, 2024, the trial underwent its most recent update on February 27, 2024. The aim is to enroll a total of 64 subjects across one designated site."

Answered by AI

What are the criteria for eligibility to participate in this experimental study?

"In order to qualify for participation in this research, individuals must have a diagnosis of type 2 diabetes and fall within the age range from 18 to 65 years old. The study aims to enroll approximately 64 participants."

Answered by AI

What are the safety profiles of Midazolam, Atorvastatin, and ECC5004 (Part B) for individuals?

"Given the Phase 1 nature of this trial, with sparse data backing safety and efficacy, Midazolam, Atorvastatin, and ECC5004 (Part B) have been rated as a level 1 for safety by our team at Power."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The main focus of this research endeavor, to be scrutinized throughout Part B and optional Part D up until Day 34, is centered on evaluating the pharmacokinetic characteristics of Rosuvastatin: specifically Cmax. Additional endpoints encompass assessing safety factors for Atorvastatin including monitoring participants for clinical laboratory abnormalities as part of Safety Assessment via lab tests, tracking adverse events (AEs) in participants taking Rosuvastatin under Safety Assessment criteria, and observing ECC5004 pharmacokinetic parameters such as Ctau denoting Observed Concentration at the End of the Dosing Interval."

Answered by AI

Is the recruitment phase for this medical study currently ongoing?

"Indeed, as per the details outlined on clinicaltrials.gov, this research endeavor is actively seeking suitable candidates. The trial was initially uploaded on February 9th, 2024 and underwent its most recent update on February 27th of the same year. Specifically, there is a requirement for 64 participants to be enrolled across one designated site."

Answered by AI