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

NCT06293742 | Completed Phase 1 FDA Drug

• 1 other identifier: EC0007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (12)

• Atorvastatin PK parameters: AUC(0-tlast)

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

  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

  Part B and optional Part D: up to Day 34

• Atorvastatin PK parameters: Cmax

  Maximum observed plasma concentration

  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

  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

  Part A and optional Part C: up to Day 11

• Rosuvastatin PK parameters: Cmax

  Maximum observed plasma concentration

  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

  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

  Part A and optional Part C: up to Day 11

• Digoxin PK parameters: Cmax

  Maximum observed plasma concentration

  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

  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

  Part B and optional Part D: up to Day 34

• Midazolam PK parameters: Cmax

  Maximum observed plasma concentration

  Part B and optional Part D: up to Day 34

Secondary Outcomes (31)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

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.

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.

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.

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.

Drug: ECC5004; Drug: Midazolam; Drug: Atorvastatin

Interventions

ECC5004 DRUG

ECC5004 tablet will be administered orally.

Digoxin, Rosuvastatin, ECC5004 (Part A); Digoxin, Rosuvastatin, ECC5004 (optional Part C); Midazolam, Atorvastatin, ECC5004 (Part B); Midazolam, Atorvastatin, ECC5004 (optional Part D)

Midazolam DRUG

Midazolam will be administered orally.

Midazolam, Atorvastatin, ECC5004 (Part B); Midazolam, Atorvastatin, ECC5004 (optional Part D)

Rosuvastatin DRUG

Rosuvastatin will be administered orally.

Digoxin, Rosuvastatin, ECC5004 (Part A); Digoxin, Rosuvastatin, ECC5004 (optional Part C)

Digoxin DRUG

Digoxin will be administered orally.

Digoxin, Rosuvastatin, ECC5004 (Part A); Digoxin, Rosuvastatin, ECC5004 (optional Part C)

Atorvastatin DRUG

Atorvastatin will be administered orally.

Midazolam, Atorvastatin, ECC5004 (Part B); Midazolam, Atorvastatin, ECC5004 (optional Part D)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eccogene: lead

Study Sites (1)

Eccogene Investigational Site

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Midazolam; Rosuvastatin Calcium; Digoxin; Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Eccogene

  Eccogene Clinical Trials

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: February 8, 2024
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)