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Based on the unblinded clinical data, the trial was terminated.
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
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Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers.
This study will be conducted in up to 3 dosing groups of 8 total subjects each.
The purpose of this trial is to determine the safety and tolerability of a single dose of ACH-000029 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohorts 1 to 3 - Participants Receiving ACH-000029 | Experimental | Each SAD cohort participant will be randomized to receive 10mg for cohort 1; up to 30mg and up to 60mg for cohorts 2 and 3 respectively dependent on dose review committee. |
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| SAD Cohorts 1 to 3 - Participants Receiving Placebo | Placebo Comparator | Each SAD cohort participant will be randomized to receive placebo on a ratio of 3:1 (active: placebo). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACH-000029 | Drug | ACH-000029 will be administered orally via a capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of subjects experiencing orthostatic hypotension at any timepoint | Orthostatic assessment will be with the criteria ≥ 20 mmHg decrease in SBP and a > 25 bpm increase in HR from supine to standing. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Maximum change in timepoint-matched systolic blood pressure and diastolic blood pressure. | Screening (Days -28 to Day -2) to end of treatment Day 7 | |
| Maximum change in timepoint-matched resting heart rate. | Screening (Days -28 to Day -2) to end of treatment Day 7 | |
| Assessment of abnormal clinical laboratory tests (Hemoglobin & mean corpuscular hemoglobin concentration) | Screening (Days -28 to Day -2) to end of treatment Day 7 | |
| Assessment of abnormal clinical laboratory tests (Hematocrit) | Screening (Days -28 to Day -2) to end of treatment Day 7 | |
| Assessment of abnormal clinical laboratory tests (Mean corpuscular volume) | Screening (Days -28 to Day -2) to end of treatment Day 7 | |
| Assessment of abnormal clinical laboratory tests (RBC count) | Screening (Days -28 to Day -2) to end of treatment Day 7 | |
| Assessment of abnormal clinical laboratory tests (WBC count (absolute and differential)) | Screening (Days -28 to Day -2) to end of treatment Day 7 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| C000712087 | ACH-000029 |
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| Placebo | Drug | Placebo will be administered orally via a capsule. |
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| Assessment of abnormal clinical laboratory tests (Platelets) |
| Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Mean platelet volume) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Anion gap, bicarbonate, calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium, creatinine, uric acid, triglycerides, urea) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Lactate Dehydrogenase (LDH), Alanine Transaminase (ALT), gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP) , aspartate aminotransferase (AST), phosphatase, creatinine phosphokinase) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Albumin) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Glomerular filtration rate) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Globulin) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Total bilirubin) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal clinical laboratory tests (Total protein) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Coagulation | Blood sample assessments will include activated partial thromboplastin time, prothrombin time-international normalized ratio. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Urinalysis (Bilirubin, blood, glucose, ketones, nitrites, protein) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Urinalysis (Leukocyte esterase) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Urinalysis (Microscopic analysis) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Urinalysis (pH) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Urinalysis (Specific gravity) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Vital signs (temperature) | Temperature will be assessed after subject has been in supine position for at least 3 minutes. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Vital signs (respiratory rate) | Respiratory rate will be assessed after subject has been in supine position for at least 3 minutes. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Vital signs (blood pressure) | Blood pressure will be assessed in supine and standing positions in each position for at least 3 minutes. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of abnormal Vital signs (heart rate) | Heart rate will be assessed in supine and standing positions in each position for at least 3 minutes. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of Physical examinations (height) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of Physical examinations (weight) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of Physical examinations (BMI) | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of Physical examinations | Subjects will be visually assessed for any abnormalities with head, eyes, ears, nose and throat; thorax; abdomen; urogenital; skin and mucosae. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Assessment of Neurological examinations | Subjects will be assessed for any abnormalities and evaluated for mental status, cranial nerves, motor system, reflexes, sensory system, coordination and station and gait. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| 12-lead ECG assessment of PR interval | Change in electrocardiograms | Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7 |
| 12-lead ECG assessment of QRS duration | Change in electrocardiograms | Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7 |
| 12-lead ECG assessment of QT interval | Change in electrocardiograms | Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7 |
| 12-lead ECG assessment of QTc | Change in electrocardiograms | Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7 |
| C-SSRS | Subjects will be interviewed to capture the occurrence, severity and frequency of suicide-related thoughts and behaviors. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Monitoring of adverse events | Any untoward medical occurrence in a subject, whether considered related to the treatment or not. | Screening (Days -28 to Day -2) to end of treatment Day 7 |
| Pharmacokinetic assessment 1 | Peak Plasma Concentration (Cmax) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 2 | Time of peak plasma concentration (Tmax) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 3 | Area under the concentration-time curve calculated to the last observable concentration at time (AUCt) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 4 | Area under the concentration-time curve from zero to infinity (AUC∞) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 5 | Apparent clearance of the drug normalized to body weight (CL/F) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 6 | Apparent clearance of the drug normalized to body weight (CL/F) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 7 | Terminal-phase elimination half-life (t1/2,z) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 8 | Cmax normalized to dose (Cmax/Dose) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 9 | Cmax normalized to dose (Cmax/Dose) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 10 | AUCt normalized to dose (AUCt/Dose) | Day 1 to end of treatment Day 7 |
| Pharmacokinetic assessment 11 | AUC∞ normalized to dose (AUC∞/Dose) | Day 1 to end of treatment Day 7 |