JPRN-jRCT2080225246CompletedPhase 1
Phase I/II Study of EA4000 -Safety in Healthy Adults and Efficacy for Colon Preparation before Colonoscopy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- EA Pharma Co., Ltd.
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 45age old (—)
- Sex
- Male
Inclusion Criteria
- •- Japanese healthy man of >= 20 and <= 45 years at the time of consent
- •- BMI >= 18.5 and <25.0 kg/m2 at the time of screening
- •- Gives voluntary written consent to participate in the study and is both able and willing to follow the study procedures
Exclusion Criteria
- •- Experienced a clinically relevant disease requiring intervention within 8 weeks prior to study treatment or had a clinically significant infection within 4 weeks prior to study treatment
- •- Has a history of seizures, epilepsy, leukemia, lymphoma, organ transplantation, autoimmune disorders, immunodeficiency, or malignancies
- •- Has a disease that may affect drug evaluation, including psychiatric, digestive tract, hepatic, renal, respiratory, endocrine, hematologic, immunological, neurological, or cardiovascular diseases as well as hereditary metabolic disorders, within 4 weeks prior to study treatment
- •- Medical history and concurrent conditions observed during screening or physical examinations, vital signs, ECGs, or clinical laboratory tests during screening or at baseline suggest clinically significant symptoms or organ insufficiency requiring treatment
- •- Fulfillment of any of the following:
- •Used any ethical drug within 4 weeks prior to study treatment or Used any OTC drug within 2 weeks prior to study treatment or Underwent strenuous exercise (e.g., marathon and weightlifting) within 2 weeks prior to study treatment.
- •- Has two or less bowel movements a week or is using a laxtative
Investigators
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