Clinical trial NCT03414294: A Study to Evaluate the Safety of K-755 in Healthy Volunteers
Official title: A Phase I Single-Center, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study to Investigate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of K-755 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kowa Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Assignment/Crossover (for food effect)
Primary purpose: OTHER

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 Criteria:

1. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
2. Males or females, of any race, between 18 and 45 years of age.
3. Body mass index (BMI) between 18.0 and 28.0 kg/m2.
4. Hematology, clinical chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.
5. No clinically significant abnormalities on the basis of medical history, physical examination findings, and vital signs.
6. All females must have a negative serum pregnancy test.
7. Able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

1. Female subject who are pregnant or breastfeeding.
2. 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.
3. Subject with any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-755.
4. 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.
5. Subject has a history of type 1 hypersensitivity to any medication and/or clinically relevant food allergies.
6. Subject has a history of drug addiction.
7. Subject has a positive screen for drugs of abuse, cotinine or alcohol.
8. Subject has a history of regular alcohol consumption within 6 months of the study.
9. 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.
10. Subject has used prescription or over-the-counter medications, dietary/nutritional supplements (except paracetamol or vitamin supplements)
11. Subject has used steroid medications (oral, inhaled, parenteral, or topical) within 30 days or 5 half-lives (whichever is longer) before study drug administration.
12. Subject has participated in an investigational drug study within 30 days or 5 half-lives (whichever is longer) before study drug administration.
13. Subject has a positive screen for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antigens/antibodies.
14. Subject has had a clinically significant acute illness within 4 weeks or other illness within 5 days before the first study drug administration.
15. 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.
16. Not suitable for entry into the study in the opinion of the Investigator.
17. Receipt of blood products within 2 months prior to Check-in.

Primary outcomes:
measure: Part A, B, C, D and E: Incidence and severity of Adverse Events
timeFrame: Up to 28 days after last administration
measure: Part A, B, C, D and E: Number of subjects with clinical laboratory test abnormalities
timeFrame: Up to 28 days after last administration
measure: Part A, B, C, D and E: Number of subjects with vital signs abnormalities
timeFrame: Up to 28 days after last administration
measure: Part A, B, C, D and E: Number of subjects with clinically significant change in body weight
timeFrame: Up to 28 days after last administration
measure: Part A, B, C, D and E: Number of subjects with abnormal findings in physical examinations
timeFrame: Up to 28 days after last administration
Secondary outcomes:
measure: Part A: AUC0-inf of K-755
timeFrame: Up to 28 days after single administration
measure: Part A: AUC0-tlast of K-755
timeFrame: Up to 28 days after single administration
measure: Part A: Cmax of K-755
timeFrame: Up to 28 days after single administration
measure: Part A: Tmax of K-755
timeFrame: Up to 28 days after single administration
measure: Part A: t1/2 of K-755
timeFrame: Up to 28 days after single administration
measure: Part B: AUC0-τ of K-755
timeFrame: Up to 28 days after repeated administration
measure: Part B: Cmax of K-755
timeFrame: Up to 28 days after repeated administration
measure: Part B: Tmax of K-755
timeFrame: Up to 28 days after repeated administration
measure: Part B: t1/2 of K-755
timeFrame: Up to 28 days after repeated administration
measure: Part C: AUC0-inf of K-755
timeFrame: Up to 14 days after single administration
measure: Part C: AUC0-tlast of K-755
timeFrame: Up to 14 days after single administration
measure: Part C: Cmax of K-755
timeFrame: Up to 14 days after single administration
measure: Part C: Tmax of K-755
timeFrame: Up to 14 days after single administration
measure: Part C: t1/2 of K-755
timeFrame: Up to 14 days after single administration
measure: Part D: AUC0-inf of K-755
timeFrame: Up to 14 days after single administration
measure: Part D: AUC0-tlast of K-755
timeFrame: Up to 14 days after single administration
measure: Part D: Cmax of K-755
timeFrame: Up to 14 days after single administration
measure: Part D: Tmax of K-755
timeFrame: Up to 14 days after single administration
measure: Part D: t1/2 of K-755
timeFrame: Up to 14 days after single administration
measure: Part E: AUC0-τ of K-755
timeFrame: Up to 14 days after single administration
measure: Part E: Cmax of K-755
timeFrame: Up to 14 days after single administration
measure: Part E: Tmax of K-755
timeFrame: Up to 14 days after single administration
measure: Part E: t1/2 of K-755
timeFrame: Up to 14 days after single administration
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX, Clinical Research Pty Ltd
state: South Australia
Study officials:
References: