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NCT06293742CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 22 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (actual)
First submitted
19 Feb 2024
Start date
8 Feb 2024
Primary completion date
15 Apr 2024
Lead sponsor
Eccogene
NCT number
NCT06293742

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 48
  • From 8 Feb 2024 to the primary completion date, 15 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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

Lab values

  • Serum calcitonin \> 20 ng/L
  • 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

Other

  • Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
AnaheimUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.