Phase I/II Study of EA4000

Phase I/II Study of EA4000 -Safety in Healthy Adults and Efficacy for Colon Preparation before Colonoscopy-

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225246

Enrollment

Registered

2020-06-26

Start date

2020-07-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

investigational material(s) Generic name etc : EA4000 INN of investigational material : - Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investig

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Japanese healthy man of >= 20 and = 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

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

Design outcomes

Primary

Measure	Time frame
safety efficacy - Adverse events - Clinical laboratory tests - Vital signs - Standard 12-lead electrocardiography - Physical examination - Bowel cleansing	—

Secondary

Measure	Time frame
efficacy other - Bowel cleansing scores	—

Countries

Japan

Outcome results