HealthyPhase 1NCT03414294
A Study to Evaluate the Safety of K-755 in Healthy Volunteers
A Phase 1 study testing K-755 Part A (SAD), K-755 Part B (MAD) and K-755 Part C (FE) in people with Healthy, run by Kowa Company, Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- K-755 Part A (SAD), K-755 Part B (MAD) and K-755 Part C (FE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Feb 2018to 14 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX, Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
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
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
- Being tested
- K-755 Part A (SAD), Placebo Part A (SAD), K-755 Part B (MAD), Placebo Part B (MAD), K-755 Part C (FE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-755 Part A (SAD)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)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)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)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)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)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)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)Drug
Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.
| Study group | Role | What they receive |
|---|---|---|
| K-755 Part A (SAD) | Experimental | Not described Receives: Drug: K-755 Part A (SAD) |
| Placebo Part A (SAD) | Placebo comparator | Not described Receives: Drug: Placebo Part A (SAD) |
| K-755 Part B (MAD) | Experimental | Not described Receives: Drug: K-755 Part B (MAD) |
| Placebo Part B (MAD) | Placebo comparator | Not described Receives: Drug: Placebo Part B (MAD) |
| K-755 Part C (FE) | Experimental | Not described Receives: Drug: K-755 Part C (FE) |
| K-755 Part D (FE) | Experimental | Not described Receives: Drug: K-755 Part D (FE) |
| K-755 Part E (MAD) | Experimental | Not described Receives: Drug: K-755 Part E (MAD) |
| Placebo Part E (MAD) | Placebo comparator | Not described Receives: Drug: Placebo Part E (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A, B, C, D and E: Incidence and severity of Adverse Events
A treatment-emergent adverse events (TEAE) will be summarized by treatment and overall, and summarized for each treatment by severity and relationship to study drug. All TEAEs leading to withdrawal, or SAEs, will be summarized.
Measured: Up to 28 days after last administration
Part A, B, C, D and E: Number of subjects with clinical laboratory test abnormalities
The clinical laboratory will include hematology (hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, platelet count, red blood cell count, white blood cell count), clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, cholesterol, creatinine, creatine phosphokinase, direct bilirubin, estimated glomerular filtration rate, gamma glutamyl transferase, glucose. inorganic phosphate, iron, lactate dehydrogenase, phosphorus, potassium, sodium, total bilirubin, total CO2, total protein, triglyceride, urea, uric acid), and urinalysis (bilirubin, blood, color and appearance, glucose, ketones, leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen, microscopic examination, electrolytes). Abnormality will be determined by the investigator.
Measured: Up to 28 days after last administration
Part A, B, C, D and E: Number of subjects with vital signs abnormalities
The vital sign will include blood pressure (mmHg), pulse rate (bpm), respiratory rate (breaths/min), and body temperature (degree Celsius). Abnormality will be determined by the investigator.
Measured: Up to 28 days after last administration
Part A, B, C, D and E: Number of subjects with clinically significant change in body weight
Change in body weight (kg) at baseline and post dose will be measured. Clinical significance will be determined by the investigator.
Measured: Up to 28 days after last administration
Part A, B, C, D and E: Number of subjects with abnormal findings in physical examinations
The physical examination will typically include general appearance, head and neck, eyes, ear, nose and throat, lymph nodes, thyroid, cardiovascular, respiratory, abdomen, nervous, skin, musculoskeletal, peripheral vascular and extremities and be performed at Investigator's discretion based on reported symptoms. Abnormality will be determined by the investigator.
Measured: Up to 28 days after last administration
Secondary outcomes (23)
Part A: AUC0-inf of K-755
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
Measured: Up to 28 days after single administration
Part A: AUC0-tlast of K-755
AUC from time zero to the time of the last measurable concentration
Measured: Up to 28 days after single administration
Part A: Cmax of K-755
Maximum plasma concentration
Measured: Up to 28 days after single administration
Part A: Tmax of K-755
Time of the observed maximum plasma concentration
Measured: Up to 28 days after single administration
Part A: t1/2 of K-755
Terminal plasma elimination half-life
Measured: Up to 28 days after single administration
Part B: AUC0-τ of K-755
AUC over the dosing interval
Measured: Up to 28 days after repeated administration
Part B: Cmax of K-755
Maximum plasma concentration
Measured: Up to 28 days after repeated administration
Part B: Tmax of K-755
Time of the observed maximum plasma concentration
Measured: Up to 28 days after repeated administration
Part B: t1/2 of K-755
Terminal plasma elimination half-life
Measured: Up to 28 days after repeated administration
Part C: AUC0-inf of K-755
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
Measured: Up to 14 days after single administration
Part C: AUC0-tlast of K-755
AUC from time zero to the time of the last measurable concentration
Measured: Up to 14 days after single administration
Part C: Cmax of K-755
Maximum plasma concentration
Measured: Up to 14 days after single administration
Part C: Tmax of K-755
Time of the observed maximum plasma concentration
Measured: Up to 14 days after single administration
Part C: t1/2 of K-755
Terminal plasma elimination half-life
Measured: Up to 14 days after single administration
Part D: AUC0-inf of K-755
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity
Measured: Up to 14 days after single administration
Part D: AUC0-tlast of K-755
AUC from time zero to the time of the last measurable concentration
Measured: Up to 14 days after single administration
Part D: Cmax of K-755
Maximum plasma concentration
Measured: Up to 14 days after single administration
Part D: Tmax of K-755
Time of the observed maximum plasma concentration
Measured: Up to 14 days after single administration
Part D: t1/2 of K-755
Terminal plasma elimination half-life
Measured: Up to 14 days after single administration
Part E: AUC0-τ of K-755
AUC over the dosing interval
Measured: Up to 14 days after single administration
Part E: Cmax of K-755
Maximum plasma concentration
Measured: Up to 14 days after single administration
Part E: Tmax of K-755
Time of the observed maximum plasma concentration
Measured: Up to 14 days after single administration
Part E: t1/2 of K-755
Terminal plasma elimination half-life
Measured: Up to 14 days after single administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start27 Feb 2018
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment/Crossover (for food effect)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414294
- Sponsor's protocol ID
- K-755-1.01AU
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2018
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03414294
- Acronym / sponsor ID
- K-755-1.01AU
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Kowa Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- Sequential Assignment/Crossover (for food effect)
| Arm | Type | Receives |
|---|---|---|
| K-755 Part A (SAD) | Experimental | Drug: K-755 Part A (SAD) |
| Placebo Part A (SAD) | Placebo comparator | Drug: Placebo Part A (SAD) |
| K-755 Part B (MAD) | Experimental | Drug: K-755 Part B (MAD) |
| Placebo Part B (MAD) | Placebo comparator | Drug: Placebo Part B (MAD) |
| K-755 Part C (FE) | Experimental | Drug: K-755 Part C (FE) |
| K-755 Part D (FE) | Experimental | Drug: K-755 Part D (FE) |
| K-755 Part E (MAD) | Experimental | Drug: K-755 Part E (MAD) |
| Placebo Part E (MAD) | Placebo comparator | Drug: Placebo Part E (MAD) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | K-755 Part A (SAD) |
| 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. | Drug | Placebo Part A (SAD) |
| 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. | Drug | K-755 Part B (MAD) |
| 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. | Drug | Placebo Part B (MAD) |
| 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. | Drug | K-755 Part C (FE) |
| 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. | Drug | K-755 Part D (FE) |
| 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. | Drug | K-755 Part E (MAD) |
| 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. | Drug | Placebo Part E (MAD) |
Primary outcome
Part A, B, C, D and E: Incidence and severity of Adverse Events
Time frame: Up to 28 days after last administration
A treatment-emergent adverse events (TEAE) will be summarized by treatment and overall, and summarized for each treatment by severity and relationship to study drug. All TEAEs leading to withdrawal, or SAEs, will be summarized.
Part A, B, C, D and E: Number of subjects with clinical laboratory test abnormalities
Time frame: Up to 28 days after last administration
The clinical laboratory will include hematology (hematocrit, hemoglobin, mean cell hemoglobin, mean cell hemoglobin concentration, mean cell volume, platelet count, red blood cell count, white blood cell count), clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, cholesterol, creatinine, creatine phosphokinase, direct bilirubin, estimated glomerular filtration rate, gamma glutamyl transferase, glucose. inorganic phosphate, iron, lactate dehydrogenase, phosphorus, potassium, sodium, total bilirubin, total CO2, total protein, triglyceride, urea, uric acid), and urinalysis (bilirubin, blood, color and appearance, glucose, ketones, leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen, microscopic examination, electrolytes). Abnormality will be determined by the investigator.
Part A, B, C, D and E: Number of subjects with vital signs abnormalities
Time frame: Up to 28 days after last administration
The vital sign will include blood pressure (mmHg), pulse rate (bpm), respiratory rate (breaths/min), and body temperature (degree Celsius). Abnormality will be determined by the investigator.
Part A, B, C, D and E: Number of subjects with clinically significant change in body weight
Time frame: Up to 28 days after last administration
Change in body weight (kg) at baseline and post dose will be measured. Clinical significance will be determined by the investigator.
Part A, B, C, D and E: Number of subjects with abnormal findings in physical examinations
Time frame: Up to 28 days after last administration
The physical examination will typically include general appearance, head and neck, eyes, ear, nose and throat, lymph nodes, thyroid, cardiovascular, respiratory, abdomen, nervous, skin, musculoskeletal, peripheral vascular and extremities and be performed at Investigator's discretion based on reported symptoms. Abnormality will be determined by the investigator.
23 secondary outcomes
Part A: AUC0-inf of K-755
Time frame: Up to 28 days after single administration
Part A: AUC0-tlast of K-755
Time frame: Up to 28 days after single administration
Part A: Cmax of K-755
Time frame: Up to 28 days after single administration
Part A: Tmax of K-755
Time frame: Up to 28 days after single administration
Part A: t1/2 of K-755
Time frame: Up to 28 days after single administration
Part B: AUC0-τ of K-755
Time frame: Up to 28 days after repeated administration
Part B: Cmax of K-755
Time frame: Up to 28 days after repeated administration
Part B: Tmax of K-755
Time frame: Up to 28 days after repeated administration
Part B: t1/2 of K-755
Time frame: Up to 28 days after repeated administration
Part C: AUC0-inf of K-755
Time frame: Up to 14 days after single administration
Part C: AUC0-tlast of K-755
Time frame: Up to 14 days after single administration
Part C: Cmax of K-755
Time frame: Up to 14 days after single administration
Part C: Tmax of K-755
Time frame: Up to 14 days after single administration
Part C: t1/2 of K-755
Time frame: Up to 14 days after single administration
Part D: AUC0-inf of K-755
Time frame: Up to 14 days after single administration
Part D: AUC0-tlast of K-755
Time frame: Up to 14 days after single administration
Part D: Cmax of K-755
Time frame: Up to 14 days after single administration
Part D: Tmax of K-755
Time frame: Up to 14 days after single administration
Part D: t1/2 of K-755
Time frame: Up to 14 days after single administration
Part E: AUC0-τ of K-755
Time frame: Up to 14 days after single administration
Part E: Cmax of K-755
Time frame: Up to 14 days after single administration
Part E: Tmax of K-755
Time frame: Up to 14 days after single administration
Part E: t1/2 of K-755
Time frame: Up to 14 days after single administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing K-755 Part A (SAD), K-755 Part B (MAD) and K-755 Part C (FE) in people with Healthy, run by Kowa Company, Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A, B, C, D and E: Incidence and severity of Adverse Events (time frame: Up to 28 days after last administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.