Type 2 Diabetes Mellitus
Conditions
Brief 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.
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.
Interventions
DRUGECC5004
ECC5004 tablet will be administered orally.
DRUGMidazolam
Midazolam will be administered orally.
DRUGRosuvastatin
Rosuvastatin will be administered orally.
DRUGDigoxin
Digoxin will be administered orally.
DRUGAtorvastatin
Atorvastatin will be administered orally.
Sponsors
Eccogene
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atorvastatin PK parameters: AUC(0-tlast) | 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) | 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 | Part B and optional Part D: up to Day 34 | Maximum observed plasma concentration |
| Rosuvastatin PK parameters: AUC(0-tlast) | 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) | 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 | Part A and optional Part C: up to Day 11 | Maximum observed plasma concentration |
| Digoxin PK parameters: AUC(0-tlast) | 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) | 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 | Part A and optional Part C: up to Day 11 | Maximum observed plasma concentration |
| Midazolam PK parameters: AUC(0-tlast) | 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) | 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 | Part B and optional Part D: up to Day 34 | Maximum observed plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through electrocardiograms (ECGs) |
| Rosuvastatin safety parameters: Number of participants with physical examination abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through physical examination |
| Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through clinical laboratory assessments |
| Digoxin safety parameters: Number of participants with adverse events (AEs) | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through adverse events |
| Digoxin safety parameters: Number of participants with vital sign abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through vital signs |
| Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through electrocardiograms (ECGs) |
| Digoxin safety parameters: Number of participants with physical examination abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through physical examination |
| Digoxin safety parameters: Number of participants with clinical laboratory abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through clinical laboratory assessments |
| Midazolam safety parameters: Number of participants with adverse events (AEs) | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through adverse events |
| Midazolam safety parameters: Number of participants with vital sign abnormalities | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through vital signs |
| Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through electrocardiograms (ECGs) |
| Midazolam safety parameters: Number of participants with physical examination abnormalities | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through physical examination |
| Midazolam safety parameters: Number of participants with clinical laboratory abnormalities | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through clinical laboratory assessments |
| ECC5004 PK parameters: AUC (0-τ) | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 | Area under the Plasma Concentration-Time Curve during the Dosing Interval |
| ECC5004 Safety parameters: Number of participants with adverse events (AEs) | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through adverse events |
| ECC5004 PK parameters: tmax | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 | Time of the maximum observed plasma concentration |
| ECC5004 PK parameters: t1/2 | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 | Apparent terminal elimination half-life |
| ECC5004 PK parameters: CL/F | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 | Apparent Clearance |
| ECC5004 PK parameters: Ctau | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 | Observed Concentration at the End of the Dosing Interval |
| ECC5004 PK parameters: AUC(0-24) | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 | Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose |
| ECC5004 Safety parameters: Number of participants with vital sign abnormalities | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through vital signs |
| ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through electrocardiograms (ECGs) |
| ECC5004 Safety parameters: Number of participants with physical examination abnormalities | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through physical examination |
| ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through clinical laboratory assessments |
| Atorvastatin safety parameters: Number of participants with adverse events (AEs) | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through adverse events |
| Atorvastatin safety parameters: Number of participants with vital sign abnormalities | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through vital signs |
| Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG) | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through electrocardiograms (ECGs) |
| Atorvastatin safety parameters: Number of participants with physical examination abnormalities | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through physical examination |
| Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities | Part B and optional Part D: up to Day 40 | Safety Assessment evaluated through clinical laboratory assessments |
| Rosuvastatin safety parameters: Number of participants with adverse events (AEs) | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through adverse events |
| Rosuvastatin safety parameters: Number of participants with vital sign abnormalities | Part A and optional Part C: up to Day 16 | Safety Assessment evaluated through vital signs |
Countries
United States
Outcome results
None listed