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This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect evaluation, Part 3; Gender-effect evaluation, Part 4; Multiple-ascending dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose, CP1050 or Placebo | Experimental |
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| Multiple ascending dose, CP1050 or Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP1050 or Placebo | Drug | Randomised, double-blinded, placebo-controlled |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of any drug-related adverse events | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events | Up to 21 days |
| Number of subjects with abnormal vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature) | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of vital signs | Up to 21 days |
| Number of subjects with abnormal clinical laboratory tests (including clinical chemistry, haematology and urinalysis) | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of clinical laboratory tests | Up to 21 days |
| Number of subjects with abnormal 12-lead safety ECG (including heart rate, RR interval, PR interval, QRS duration, QT interval, and QT interval corrected for heart rate using Fridericia's method [QTcF]) | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead safety ECG | Up to 21 days |
| Number of subjects with abnormal 12-lead continuous (24-hour) ECG (including mean hourly heart rate and incidence of arrhythmia assessed as per the ECG Alert Criteria) | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of 12-lead continuous (24-hour) ECG | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 21 days | |
| Area under the plasma concentration-time curve (AUC) | Up to 21 days | |
| Time of maximum observed plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Ltd. | Leeds | LS2 9LH | United Kingdom |
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| Number of subjects with abnormal Pulmonary function tests (including FEV1, FVC, FEF25-75 and DLCO [Part 4 only]) | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of pulmonary function tests | Up to 21 days |
| Number of subjects with abnormal ophthalmological findings assessed by fundoscopy or OCT | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of ophthalmological assessments | Up to 21 days |
| Number of subjects with abnormal physical examinations | To evaluate the safety and tolerability of CP1050 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of physical examinations | Up to 21 days |
| Up to 21 days |
| Apparent plasma terminal elimination half-life (T1/2) | Up to 21 days |
| The lowest absolute value of lymphocytes at postdose (nadir) | Up to 21 days |
| The lowest percentage of baseline (nadir [%]) | Up to 21 days |
| Time of nadir (Tnadir) | Up to 21 days |
| Area under the effectiveness curve (AUCE) | Up to 21 days |