A Study to Evaluate the Safety of K-755 in Healthy Volunteers

NCT ID: NCT03414294

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2019-11-14

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

K-755 Part A (SAD)

Group Type: EXPERIMENTAL

K-755 Part A (SAD)

Intervention Type: DRUG

Single ascending dose (SAD). There will be 7 cohorts in the Part A. Three quarters of subjects will receive K-755 tablet orally in a double-blind fashion.

Placebo Part A (SAD)

Group Type: PLACEBO_COMPARATOR

Placebo Part A (SAD)

Intervention Type: DRUG

Single ascending dose (SAD). In Part A, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.

K-755 Part B (MAD)

Group Type: EXPERIMENTAL

K-755 Part B (MAD)

Intervention Type: DRUG

Multiple ascending dose (MAD). There will be 4 cohorts in the Part B. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.

Placebo Part B (MAD)

Group Type: PLACEBO_COMPARATOR

Placebo Part B (MAD)

Intervention Type: DRUG

Multiple ascending dose (MAD). In Part B, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.

K-755 Part C (FE)

Group Type: EXPERIMENTAL

K-755 Part C (FE)

Intervention Type: DRUG

Food effect (FE). All subjects in Part C will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.

K-755 Part D (FE)

Group Type: EXPERIMENTAL

K-755 Part D (FE)

Intervention Type: DRUG

Food effect (FE). All subjects in Part D will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.

K-755 Part E (MAD)

Group Type: EXPERIMENTAL

K-755 Part E (MAD)

Intervention Type: DRUG

Multiple ascending dose (MAD). There will be 2 cohorts in the Part E. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.

Placebo Part E (MAD)

Group Type: PLACEBO_COMPARATOR

Placebo Part E (MAD)

Intervention Type: DRUG

Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.

Interventions

K-755 Part A (SAD)

Single ascending dose (SAD). There will be 7 cohorts in the Part A. Three quarters of subjects will receive K-755 tablet orally in a double-blind fashion.

Intervention Type: DRUG

Placebo Part A (SAD)

Single ascending dose (SAD). In Part A, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.

Intervention Type: DRUG

K-755 Part B (MAD)

Multiple ascending dose (MAD). There will be 4 cohorts in the Part B. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.

Intervention Type: DRUG

Placebo Part B (MAD)

Multiple ascending dose (MAD). In Part B, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.

Intervention Type: DRUG

K-755 Part C (FE)

Food effect (FE). All subjects in Part C will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.

Intervention Type: DRUG

K-755 Part D (FE)

Food effect (FE). All subjects in Part D will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.

Intervention Type: DRUG

K-755 Part E (MAD)

Multiple ascending dose (MAD). There will be 2 cohorts in the Part E. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.

Intervention Type: DRUG

Placebo Part E (MAD)

Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kowa Company, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMAX, Clinical Research Pty Ltd

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

K-755-1.01AU

Identifier Type: -

Identifier Source: org_study_id