Status:
COMPLETED
A Study to Evaluate the Safety of K-755 in Healthy Volunteers
Lead Sponsor:
Kowa Company, Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study designed to explore the safety, tolerability and pharmacokinetics of K-755 following oral administration to healthy male and female volunteers.
Eligibility Criteria
Inclusion
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Males or females, of any race, between 18 and 45 years of age.
- Body mass index (BMI) between 18.0 and 28.0 kg/m2.
- Hematology, clinical chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.
- No clinically significant abnormalities on the basis of medical history, physical examination findings, and vital signs.
- All females must have a negative serum pregnancy test.
- Able and willing to comply with the protocol and study procedures.
Exclusion
- Female subject who are pregnant or breastfeeding.
- Subject with presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- Subject with any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-755.
- Subject with presence of an active malignancy or within the past 5 years a malignancy of any type, other than basal cell carcinoma of the skin.
- Subject has a history of type 1 hypersensitivity to any medication and/or clinically relevant food allergies.
- Subject has a history of drug addiction.
- Subject has a positive screen for drugs of abuse, cotinine or alcohol.
- Subject has a history of regular alcohol consumption within 6 months of the study.
- Subject has smoked tobacco within 6 months prior to Check-in, or has used non-inhaled tobacco- or nicotine-containing products within 3 months prior to Check-in.
- Subject has used prescription or over-the-counter medications, dietary/nutritional supplements (except paracetamol or vitamin supplements)
- Subject has used steroid medications (oral, inhaled, parenteral, or topical) within 30 days or 5 half-lives (whichever is longer) before study drug administration.
- Subject has participated in an investigational drug study within 30 days or 5 half-lives (whichever is longer) before study drug administration.
- Subject has a positive screen for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antigens/antibodies.
- Subject has had a clinically significant acute illness within 4 weeks or other illness within 5 days before the first study drug administration.
- Subject or a family member of the subject is a member of the professional or ancillary personnel working at the investigative site involved in the study.
- Not suitable for entry into the study in the opinion of the Investigator.
- Receipt of blood products within 2 months prior to Check-in.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2019
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03414294
Start Date
February 27 2018
End Date
November 14 2019
Last Update
January 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CMAX, Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000