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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| K-755 Part A (SAD) | Experimental |
| |
| Placebo Part A (SAD) | Placebo Comparator |
| |
| K-755 Part B (MAD) | Experimental |
| |
| Placebo Part B (MAD) | Placebo Comparator |
| |
| K-755 Part C (FE) | Experimental |
| |
| K-755 Part D (FE) | Experimental |
| |
| K-755 Part E (MAD) | Experimental |
| |
| Placebo Part E (MAD) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to 28 days after last administration |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: AUC0-inf of K-755 | Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX, Clinical Research Pty Ltd | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D064346 | Sagittal Abdominal Diameter |
| C110804 | mycophenolic adenine dinucleotide |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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Sequential Assignment/Crossover (for food effect)
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Masking for Part A (SAD) , Part B (MAD), Part E (MAD) open for Part C (FE) and Part D (FE)
| Placebo Comparator |
|
| 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. |
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| 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. |
|
| 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. | Up to 28 days after last administration |
| Up to 28 days after single administration |
| Part A: Cmax of K-755 | Maximum plasma concentration | Up to 28 days after single administration |
| Part A: Tmax of K-755 | Time of the observed maximum plasma concentration | Up to 28 days after single administration |
| Part A: t1/2 of K-755 | Terminal plasma elimination half-life | Up to 28 days after single administration |
| Part B: AUC0-τ of K-755 | AUC over the dosing interval | Up to 28 days after repeated administration |
| Part B: Cmax of K-755 | Maximum plasma concentration | Up to 28 days after repeated administration |
| Part B: Tmax of K-755 | Time of the observed maximum plasma concentration | Up to 28 days after repeated administration |
| Part B: t1/2 of K-755 | Terminal plasma elimination half-life | 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 | 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 | Up to 14 days after single administration |
| Part C: Cmax of K-755 | Maximum plasma concentration | Up to 14 days after single administration |
| Part C: Tmax of K-755 | Time of the observed maximum plasma concentration | Up to 14 days after single administration |
| Part C: t1/2 of K-755 | Terminal plasma elimination half-life | 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 | 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 | Up to 14 days after single administration |
| Part D: Cmax of K-755 | Maximum plasma concentration | Up to 14 days after single administration |
| Part D: Tmax of K-755 | Time of the observed maximum plasma concentration | Up to 14 days after single administration |
| Part D: t1/2 of K-755 | Terminal plasma elimination half-life | Up to 14 days after single administration |
| Part E: AUC0-τ of K-755 | AUC over the dosing interval | Up to 14 days after single administration |
| Part E: Cmax of K-755 | Maximum plasma concentration | Up to 14 days after single administration |
| Part E: Tmax of K-755 | Time of the observed maximum plasma concentration | Up to 14 days after single administration |
| Part E: t1/2 of K-755 | Terminal plasma elimination half-life | Up to 14 days after single administration |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |