ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants

Eccogene48 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

ECC5004DRUG

ECC5004 tablet will be administered orally.

MidazolamDRUG

Midazolam will be administered orally.

RosuvastatinDRUG

Rosuvastatin will be administered orally.

Digoxin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Eccogene Investigational Site

Anaheim, California, United States

Outcomes

Primary Outcomes

Atorvastatin PK parameters: AUC(0-tlast)

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

Time frame: 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

Time frame: Part B and optional Part D: up to Day 34

Atorvastatin PK parameters: Cmax

Maximum observed plasma concentration

Time frame: 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

Time frame: 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

Time frame: Part A and optional Part C: up to Day 11

Rosuvastatin PK parameters: Cmax

Maximum observed plasma concentration

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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Secondary Outcomes

ECC5004 Safety parameters: Number of participants with adverse events (AEs)

Safety Assessment evaluated through adverse events

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

Safety Assessment evaluated through vital signs

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

Safety Assessment evaluated through electrocardiograms (ECGs)

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

Safety Assessment evaluated through physical examination

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

Safety Assessment evaluated through clinical laboratory assessments

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)

Safety Assessment evaluated through adverse events

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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