Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects
Lead Sponsor:
Kyorin Pharmaceutical Co.,Ltd
Conditions:
Healthy
Eligibility:
All Genders
20-55 years
Phase:
PHASE1
Brief Summary
This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, in...
Eligibility Criteria
Inclusion
- Key
- Male or female adults, between 20 and 55 years of age, inclusive.
- Body weight ≥50 kg, with body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive.
- In good health, at Screening or Day -1 as assessed by the Investigator.
- Females will not be pregnant or lactating, and females of childbearing potential will agree to use contraception and to not donate eggs (ova, oocytes). Males will agree to use contraception and to not donate sperm.
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
- Key
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing.
- Use or intend to use any prescription medications/products within 14 days or 5 half-lives (whichever is longer) prior to dosing, unless deemed acceptable by the Investigator.
- Use or intend to use slow release medications/products considered to still be active within 14 days prior to dosing, unless deemed acceptable by the Investigator.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to dosing, unless deemed acceptable by the Investigator.
- Use of tobacco or nicotine-containing products within 3 months prior to Day -1, or positive cotinine test at screening or Day -1.
- Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to Day -1.
- Consumption of caffeine- or xanthine-containing foods and beverages within 36 hours prior to Day -1.
- Participation in strenuous exercised within 7 days prior to Day -1.
- Receipt of blood products within 2 months prior to Day -1.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or have previously received the investigational medicinal product (IMP).
- Subject is, in the opinion of the Investigator, unlikely to comply with the protocol or unsuitable to participate in this study for any reason.
- Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
May 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04908800
Start Date
May 27 2021
End Date
April 21 2022
Last Update
January 8 2024
Active Locations (1)
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1
Labcorp Clinical Research
Leeds, United Kingdom, LS2 9LH