JPRN-jRCT2071230052
Recruiting
Phase 1
Phase I study to investigate the pharmacokinetics, food effect, and safety of AKP-009 after single and multiple oral doses
Shimomiya Kazuhiro0 sites81 target enrollmentAugust 23, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shimomiya Kazuhiro
- Enrollment
- 81
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals who are capable of understanding the nature of the study and can provide written voluntary consent to participate in the study
- •\- Healthy adult Japanese men 65 to 85 years of age (inclusive) at the time of informed consent for the multiple\-dose 20 mg\-H group, and healthy adult Japanese men 20 to 40 years of age (inclusive) at the time of informed consent for the other groups
- •\- Individuals with a BMI of \>\= 18\.5 and \<\= 25\.0 at screening
Exclusion Criteria
- •\- Individuals with current or previous disease considered inappropriate for participation in the study, such as liver disorders, kidney disorders, cerebrovascular/cardiovascular disorders, gastrointestinal disorders, blood diseases, or endocrine diseases
- •\- Individuals with drug allergy
- •\- Individuals with current or previous convulsive disorder such as epilepsy
- •\- Individuals with current or previous alcoholism
- •\- Individuals who test positive for drug abuse at screening
- •\- Individuals who test positive for HBs antigen, HCV antibody, HIV antigen/antibody, or serological syphilis at screening
- •\- Individuals who weigh less than 50 kg at screening
- •\- Individuals from whom at least 200 mL or 400 mL of blood had been collected within 4 or 12 weeks before study treatment, respectively, or who had donated blood component within 2 weeks before study treatment
- •\- Individuals who are considered by the investigator/subinvestigator to be unsuitable for participation in the study based on the medication status within 1 week before study treatment
- •\- Individuals who had participated in another clinical trial within 16 weeks before study treatment
Outcomes
Primary Outcomes
Not specified
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