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This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.
This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3293 | Experimental | AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1. |
|
| Placebo | Placebo Comparator | Placebo given (2 subjects in each cohort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3293 | Drug | Oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Adverse Events | Safety - Number of subjects reporting any adverse events during the study | Day of first dose to follow up |
| Measure | Description | Time Frame |
|---|---|---|
| PK Cmax - Overall Study | Pharmacokinetic maximum concentration | 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr |
| PK AUC - Overall Study (SAD & MAD Parts) | Pharmacokintic Area Under the Curve (0 to t) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Alexander, MD | AstraZeneca | Study Director |
| Kei Sakamoto, MD, PhD | Sugioka Memorial Hospital, Medical Co. LTA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan |
Single Japanese Centre: SAD Part 1: 24 young adult subjects in 3 cohorts of 8, 2 placebo and 6 active AZD3293 dose (15 mg, 50 mg, 150 mg); MAD Part 2:16 elderly subjects in 2 Cohorts of 8, randomized 2 placebo and 6 active dose AZD3293 (15 mg, 50 mg) - Only data on subjests enrolled into cohorts was included in the data base for reporting
Healthy subjects, adult and elderly Japanese vlounteers, male and female (non-fertile); First patient enrolled 24 Dec 2013, last patient completed 29 Jul 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Part 1 | Placebo Part 1 - SAD |
| FG001 | AZD3293 15 mg Part 1 | AZD3293 15 mg Part 1 - SAD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 - Cohorts 1-3 Adult Subjects |
|
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| Drug |
Oral solution |
|
| 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr |
| Biomarker | Biomarker (Abeta 1-40; A beta 1-42) % change from baseline | Pre dose vs Day 14 |
| FG002 |
| AZD3293 50 mg Part 1 |
AZD3293 50 mg Part 1 - SAD |
| FG003 | AZD3293 150 mg Part 1 | AZD3293 150 mg Part 1 - SAD |
| FG004 | AZD3293 15 mg Part 2 | AZD3293 15 mg Part 2 -MAD |
| FG005 | AZD3293 50 mg Part 2 | AZD3293 50 mg Part 2 - MAD |
| FG006 | Placebo Part 2 | Placebo Part 2 - MAD |
| COMPLETED |
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| NOT COMPLETED |
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| Part 2 - Elderly Subjects Cohorts 4 & 5 |
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|
Part 1 - Single Ascending Dose - healthy adults, Part 2 - Multiple Ascending Doses - healthy elderly
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Part 1 | Placebo Part 1 - SAD |
| BG001 | AZD3293 15 mg Part 1 | AZD3293 15 mg Part 1 - SAD |
| BG002 | AZD3293 50 mg Part 1 | AZD3293 50 mg Part 1 - SAD |
| BG003 | AZD3293 150 mg Part 1 | AZD3293 150 mg Part 1 - SAD |
| BG004 | AZD3293 15 mg Part 2 | AZD3293 15 mg Part 2 -MAD |
| BG005 | AZD3293 50 mg Part 2 | AZD3293 50 mg Part 2 - MAD |
| BG006 | Placebo Part 2 | Placebo Part 2 - MAD |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at study enrollment | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | PK Cmax - Overall Study | Pharmacokinetic maximum concentration | Pharmacokinetic | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr |
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| Secondary | PK AUC - Overall Study (SAD & MAD Parts) | Pharmacokintic Area Under the Curve (0 to t) | healthy Japanese participants | Posted | Geometric Mean | Geometric Coefficient of Variation | hr.ng/mL | 0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr |
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| Secondary | Biomarker | Biomarker (Abeta 1-40; A beta 1-42) % change from baseline | Pharmacodynamic | Posted | Mean | Standard Deviation | % change from baseline | Pre dose vs Day 14 |
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| Primary | Safety - Adverse Events | Safety - Number of subjects reporting any adverse events during the study | Safety | Posted | Number | Participants | Day of first dose to follow up |
|
up to 10 days after last dose, for Part 1: 7 to 10 days; for Part 2: 21 to 24 days
Treatment emergent AEs were recorded from day of 1st dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Part 1 | Placebo Part 1 - SAD | 0 | 6 | 1 | 6 | ||
| EG001 | AZD3293 15 mg Part 1 | AZD3293 15 mg Part 1 - SAD | 0 | 6 | 1 | 6 | ||
| EG002 | AZD3293 50 mg Part 1 | AZD3293 50 mg Part 1 - SAD | 0 | 6 | 1 | 6 | ||
| EG003 | AZD3293 150 mg Part 1 | AZD3293 150 mg Part 1 - SAD | 0 | 6 | 0 | 6 | ||
| EG004 | AZD3293 15 mg Part 2 | AZD3293 15 mg Part 2 -MAD | 0 | 6 | 2 | 6 | ||
| EG005 | AZD3293 50 mg Part 2 | AZD3293 50 mg Part 2 - MAD | 0 | 6 | 2 | 6 | ||
| EG006 | Placebo Part 2 | Placebo Part 2 - MAD | 0 | 4 | 1 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Medra | Non-systematic Assessment |
| |
| Nasopharengitis | Infections and infestations | Medra | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | Medra | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | Medra | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Neuroscience iMed | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| C000608388 | lanabecestat |
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| Elderly Adults |
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| Male |
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| MAD -Day 10 steady state |
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| MAD - Day 14 steady state |
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| Units | Counts |
|---|---|
| Participants |
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|
AZD3293 50 mg Part 2 - MAD |
| OG006 | Placebo Part 2 | Placebo Part 2 - MAD |
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|
Placebo Part 1 - SAD |
| OG006 | Placebo Part2 | Placebo Part 2 - MAD |
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