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This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.
The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed Cohort | Other | PBT2 250 mg is administered orally following a high fat breakfast |
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| Fasted Cohort | Other | PBT2 250 mg is administered orally following a 10 hour period of fasting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fed Cohort PBT2 | Drug | PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve (AUC 0-t) | prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events | Up to 15 days after the first dose of PBT2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Herd | Prana Biotechnology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Studies - Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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Participants were screened and enrolled at 1 site in Australia
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| ID | Title | Description |
|---|---|---|
| FG000 | Fed Cohort First Then Fasted Cohort | Per sequence, FED Cohort first then FASTED Cohort. Nine participants in the FED Cohort. PBT2 250 mg is administered orally following a high fat breakfast first, following a period of fasting for 10 hours and a high fat breakfast. Participants then cross over into the FASTED Cohort. |
| FG001 | Fasted Cohort First Then Fed Cohort | Per sequence, FASTED Cohort first, then FED Cohort. Nine participants in the Fasted Cohort. PBT2 250 mg is administered orally following a 10 hour period of fasting and without food first. Participants then cross over into the FED Cohort. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants are first administered PBT2 250 mg orally following a period of fasting for 10 hours and a high fat breakfast in the FED cohort. Participants then cross over into the FASTED Cohort and receive PBT2 250 mg orally after a period of fasting of 10 hours and without food. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-Time Curve (AUC 0-t) | PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters. | Posted | Mean | Standard Deviation | h*ng/mL | prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose |
|
All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
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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 | Fed Cohort | PBT2 250 mg is administered orally following a high fat breakfast Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Caroline Herd | Prana Biotechnology | +61393494906 | info@pranabio.com |
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| Fasted Cohort PBT2 | Drug | PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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PBT2 250 mg is administered orally following a 10 hour period of fasting
Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort.
|
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| Secondary | Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events | Safety Population, as defined as all participants who received at least one dose of study drug | Posted | Number | participants | Up to 15 days after the first dose of PBT2 |
|
|
|
| 0 |
| 17 |
| 6 |
| 17 |
| EG001 | Fasted Cohort | PBT2 250 mg is administered orally following a 10 hour period of fasting Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort. | 0 | 18 | 2 | 18 |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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