Type 2 Diabetes MellitusPhase 1NCT06293742
ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants
A Phase 1 study testing ECC5004, Midazolam and Rosuvastatin in people with Type 2 Diabetes Mellitus, run by Eccogene at 1 site in United States.
Trial summary
This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam 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, Midazolam and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 15 Apr 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
- Male and female participants of non-childbearing potential (NCBP) between the ages of 18 to 65 years of age
- 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 treatment, or plan to donate blood during this trial and within 1 month after the last dose of study treatment
- 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
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- 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
- Used or plan to use any drugs or substances that can modulate the activity of CYP3A4 within at least 14 days prior to the first dose of study treatment until after their final follow up visit
- Use of drugs with enzyme-inducing properties such as St. John's Wort within 3 weeks prior to the first dose of study treatment until after their final follow up visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Eccogene Investigational Site
Anaheim, California, 92801
About this study
Official title: A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of ECC5004 on the Single Dose Pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants
This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants.
Read the detailed description
The study consists of four parts (Part A, Part B, optional Part C and optional Part D), each with approximately 16 healthy participants enrolled. Part A and optional Part C of the study will have the same study design with two treatment periods, except that ECC5004 will be administered at a higher dose level in the optional Part C. Part B and optional Part D of the study will have the same study design with five treatment periods, except that ECC5004 will be administered at a higher dose level in optional Part D. Rosuvastatin and Digoxin will be administered alone or in combination with EC5004 in Part A and optional Part C. Atorvastatin and Midazolam will be administered alone or in combination with ECC5004 in Part B and optional Part D. The conduct of Part C and Part D with an increased dose of ECC5004 may be conducted as optional parts.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- ECC5004, Midazolam, Rosuvastatin, Digoxin, Atorvastatin
- 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
ECC5004 tablet will be administered orally.
MidazolamDrug
Midazolam will be administered orally.
RosuvastatinDrug
Rosuvastatin will be administered orally.
DigoxinDrug
Digoxin will be administered orally.
AtorvastatinDrug
Atorvastatin will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Digoxin, Rosuvastatin, ECC5004 (Part A) | Experimental | 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. Receives: Drug: ECC5004; Drug: Rosuvastatin; Drug: Digoxin |
| Midazolam, Atorvastatin, ECC5004 (Part B) | Experimental | 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. Receives: Drug: ECC5004; Drug: Midazolam; Drug: Atorvastatin |
| Digoxin, Rosuvastatin, ECC5004 (optional Part C) | Experimental | 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. Receives: Drug: ECC5004; Drug: Rosuvastatin; Drug: Digoxin |
| Midazolam, Atorvastatin, ECC5004 (optional Part D) | Experimental | 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. Receives: Drug: ECC5004; Drug: Midazolam; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atorvastatin PK parameters: AUC(0-tlast)
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Measured: Part B and optional Part D: up to Day 34
Atorvastatin PK parameters: AUC(0-inf)
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Measured: Part B and optional Part D: up to Day 34
Atorvastatin PK parameters: Cmax
Maximum observed plasma concentration
Measured: Part B and optional Part D: up to Day 34
Rosuvastatin PK parameters: AUC(0-tlast)
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Measured: Part A and optional Part C: up to Day 11
Rosuvastatin PK parameters: AUC(0-inf)
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Measured: Part A and optional Part C: up to Day 11
Rosuvastatin PK parameters: Cmax
Maximum observed plasma concentration
Measured: Part A and optional Part C: up to Day 11
Digoxin PK parameters: AUC(0-tlast)
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Measured: Part A and optional Part C: up to Day 11
Digoxin PK parameters: AUC(0-inf)
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Measured: Part A and optional Part C: up to Day 11
Digoxin PK parameters: Cmax
Maximum observed plasma concentration
Measured: Part A and optional Part C: up to Day 11
Midazolam PK parameters: AUC(0-tlast)
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Measured: Part B and optional Part D: up to Day 34
Midazolam PK parameters: AUC(0-inf)
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Measured: Part B and optional Part D: up to Day 34
Midazolam PK parameters: Cmax
Maximum observed plasma concentration
Measured: Part B and optional Part D: up to Day 34
Secondary outcomes (31)
ECC5004 Safety parameters: Number of participants with adverse events (AEs)
Safety Assessment evaluated through adverse events
Measured: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with vital sign abnormalities
Safety Assessment evaluated through vital signs
Measured: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Safety Assessment evaluated through electrocardiograms (ECGs)
Measured: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with physical examination abnormalities
Safety Assessment evaluated through physical examination
Measured: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities
Safety Assessment evaluated through clinical laboratory assessments
Measured: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with adverse events (AEs)
Safety Assessment evaluated through adverse events
Measured: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with vital sign abnormalities
Safety Assessment evaluated through vital signs
Measured: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG)
Safety Assessment evaluated through electrocardiograms (ECGs)
Measured: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with physical examination abnormalities
Safety Assessment evaluated through physical examination
Measured: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities
Safety Assessment evaluated through clinical laboratory assessments
Measured: Part B and optional Part D: up to Day 40
Rosuvastatin safety parameters: Number of participants with adverse events (AEs)
Safety Assessment evaluated through adverse events
Measured: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with vital sign abnormalities
Safety Assessment evaluated through vital signs
Measured: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Safety Assessment evaluated through electrocardiograms (ECGs)
Measured: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with physical examination abnormalities
Safety Assessment evaluated through physical examination
Measured: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities
Safety Assessment evaluated through clinical laboratory assessments
Measured: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with adverse events (AEs)
Safety Assessment evaluated through adverse events
Measured: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with vital sign abnormalities
Safety Assessment evaluated through vital signs
Measured: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Safety Assessment evaluated through electrocardiograms (ECGs)
Measured: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with physical examination abnormalities
Safety Assessment evaluated through physical examination
Measured: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with clinical laboratory abnormalities
Safety Assessment evaluated through clinical laboratory assessments
Measured: Part A and optional Part C: up to Day 16
Midazolam safety parameters: Number of participants with adverse events (AEs)
Safety Assessment evaluated through adverse events
Measured: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with vital sign abnormalities
Safety Assessment evaluated through vital signs
Measured: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Safety Assessment evaluated through electrocardiograms (ECGs)
Measured: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with physical examination abnormalities
Safety Assessment evaluated through physical examination
Measured: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with clinical laboratory abnormalities
Safety Assessment evaluated through clinical laboratory assessments
Measured: Part B and optional Part D: up to Day 40
ECC5004 PK parameters: AUC (0-τ)
Area under the Plasma Concentration-Time Curve during the Dosing Interval
Measured: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: AUC(0-24)
Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose
Measured: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: tmax
Time of the maximum observed plasma concentration
Measured: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: t1/2
Apparent terminal elimination half-life
Measured: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: CL/F
Apparent Clearance
Measured: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: Ctau
Observed Concentration at the End of the Dosing Interval
Measured: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start8 Feb 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eccogene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eccogene, Study director, Eccogene Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293742
- Sponsor's protocol ID
- EC0007
- Status last verified
- Jul 2024
- First submitted
- 19 Feb 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of ECC5004 on the Single Dose Pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants
- ClinicalTrials.gov ID
- NCT06293742
- Acronym / sponsor ID
- EC0007
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- EccogeneIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants.
Detailed description
The study consists of four parts (Part A, Part B, optional Part C and optional Part D), each with approximately 16 healthy participants enrolled. Part A and optional Part C of the study will have the same study design with two treatment periods, except that ECC5004 will be administered at a higher dose level in the optional Part C. Part B and optional Part D of the study will have the same study design with five treatment periods, except that ECC5004 will be administered at a higher dose level in optional Part D. Rosuvastatin and Digoxin will be administered alone or in combination with EC5004 in Part A and optional Part C. Atorvastatin and Midazolam will be administered alone or in combination with ECC5004 in Part B and optional Part D. The conduct of Part C and Part D with an increased dose of ECC5004 may be conducted as optional parts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Digoxin, Rosuvastatin, ECC5004 (Part A) | Experimental | Drug: ECC5004, Drug: Rosuvastatin, Drug: DigoxinPart 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. |
| Midazolam, Atorvastatin, ECC5004 (Part B) | Experimental | Drug: ECC5004, Drug: Midazolam, Drug: AtorvastatinPart 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. |
| Digoxin, Rosuvastatin, ECC5004 (optional Part C) | Experimental | Drug: ECC5004, Drug: Rosuvastatin, Drug: DigoxinOptional 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. |
| Midazolam, Atorvastatin, ECC5004 (optional Part D) | Experimental | Drug: ECC5004, Drug: Midazolam, Drug: AtorvastatinOptional 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants of non-childbearing potential (NCBP) between the ages of 18 to 65 years of age
- 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
Key exclusion criteria (11 listed)
- 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 treatment, or plan to donate blood during this trial and within 1 month after the last dose of study treatment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECC5004ECC5004 tablet will be administered orally. | Drug | Digoxin, Rosuvastatin, ECC5004 (Part A), Digoxin, Rosuvastatin, ECC5004 (optional Part C), Midazolam, Atorvastatin, ECC5004 (Part B), Midazolam, Atorvastatin, ECC5004 (optional Part D) |
| MidazolamMidazolam will be administered orally. | Drug | Midazolam, Atorvastatin, ECC5004 (Part B), Midazolam, Atorvastatin, ECC5004 (optional Part D) |
| RosuvastatinRosuvastatin will be administered orally. | Drug | Digoxin, Rosuvastatin, ECC5004 (Part A), Digoxin, Rosuvastatin, ECC5004 (optional Part C) |
| DigoxinDigoxin will be administered orally. | Drug | Digoxin, Rosuvastatin, ECC5004 (Part A), Digoxin, Rosuvastatin, ECC5004 (optional Part C) |
| AtorvastatinAtorvastatin will be administered orally. | Drug | Midazolam, Atorvastatin, ECC5004 (Part B), Midazolam, Atorvastatin, ECC5004 (optional Part D) |
Primary outcome
Atorvastatin PK parameters: AUC(0-tlast)
Time frame: Part B and optional Part D: up to Day 34
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Atorvastatin PK parameters: AUC(0-inf)
Time frame: Part B and optional Part D: up to Day 34
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Atorvastatin PK parameters: Cmax
Time frame: Part B and optional Part D: up to Day 34
Maximum observed plasma concentration
Rosuvastatin PK parameters: AUC(0-tlast)
Time frame: Part A and optional Part C: up to Day 11
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Rosuvastatin PK parameters: AUC(0-inf)
Time frame: Part A and optional Part C: up to Day 11
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Rosuvastatin PK parameters: Cmax
Time frame: Part A and optional Part C: up to Day 11
Maximum observed plasma concentration
Digoxin PK parameters: AUC(0-tlast)
Time frame: Part A and optional Part C: up to Day 11
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Digoxin PK parameters: AUC(0-inf)
Time frame: Part A and optional Part C: up to Day 11
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Digoxin PK parameters: Cmax
Time frame: Part A and optional Part C: up to Day 11
Maximum observed plasma concentration
Midazolam PK parameters: AUC(0-tlast)
Time frame: Part B and optional Part D: up to Day 34
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration
Midazolam PK parameters: AUC(0-inf)
Time frame: Part B and optional Part D: up to Day 34
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Midazolam PK parameters: Cmax
Time frame: Part B and optional Part D: up to Day 34
Maximum observed plasma concentration
31 secondary outcomes
ECC5004 Safety parameters: Number of participants with adverse events (AEs)
Time frame: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with vital sign abnormalities
Time frame: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with physical examination abnormalities
Time frame: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities
Time frame: Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with adverse events (AEs)
Time frame: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with vital sign abnormalities
Time frame: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG)
Time frame: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with physical examination abnormalities
Time frame: Part B and optional Part D: up to Day 40
Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities
Time frame: Part B and optional Part D: up to Day 40
Rosuvastatin safety parameters: Number of participants with adverse events (AEs)
Time frame: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with vital sign abnormalities
Time frame: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with physical examination abnormalities
Time frame: Part A and optional Part C: up to Day 16
Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities
Time frame: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with adverse events (AEs)
Time frame: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with vital sign abnormalities
Time frame: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with physical examination abnormalities
Time frame: Part A and optional Part C: up to Day 16
Digoxin safety parameters: Number of participants with clinical laboratory abnormalities
Time frame: Part A and optional Part C: up to Day 16
Midazolam safety parameters: Number of participants with adverse events (AEs)
Time frame: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with vital sign abnormalities
Time frame: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with physical examination abnormalities
Time frame: Part B and optional Part D: up to Day 40
Midazolam safety parameters: Number of participants with clinical laboratory abnormalities
Time frame: Part B and optional Part D: up to Day 40
ECC5004 PK parameters: AUC (0-τ)
Time frame: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: AUC(0-24)
Time frame: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: tmax
Time frame: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: t1/2
Time frame: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: CL/F
Time frame: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
ECC5004 PK parameters: Ctau
Time frame: Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eccogene study director
Eccogene Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ECC5004, Midazolam and Rosuvastatin 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 6 inclusion and 11 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 22 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?
Atorvastatin PK parameters: AUC(0-tlast) (time frame: Part B and optional Part D: up to Day 34). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2024.