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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000389-24 | EudraCT Number |
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The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absolute Bioavailability | Experimental | IV PBT2 microtracer and oral PBT2 single dose |
|
| Radiolabelled AME | Experimental | oral 14C PBT2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV PBT2 microtracer and oral PBT2 single dose | Drug |
| ||
| oral 14C-PBT2 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bioavailability of PBT2 (F%) | Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug). | 0 to 72 hours post oral dose |
| Mass Balance | Amount excreted as a percentage of the administered dose (%Ae) | 168 h (7 days) post dose |
| Measure | Description | Time Frame |
|---|---|---|
| IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last) | Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 . | 0 to 72 h post oral dose |
| Oral PK Profile of PBT2 as Assessed by AUC(0-last) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Herd, PhD | Prana Biotechnology Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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Participants were screened and enrolled into one study site in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two. In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part One (4 Days) |
| |||||||||||||
| Part Two (up to 6 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered. |
| 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 | Absolute Bioavailability of PBT2 (F%) | Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug). | PK Population | Posted | Mean | Standard Deviation | percentage of absolute bioavailability | 0 to 72 hours post oral dose |
|
Reported AEs from dosing in Part 1 to the end of the study (Day 15 to 20).
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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 | All Study Participants | In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two. In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Dianne Angus | Prana Biotechnology | +61 393494906 | info@pranabio.com |
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| Drug |
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Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 . |
| 72 h post oral dose |
| Safety and Tolerability of PBT2 | As assessed by the number of participants with adverse events | 72 h post oral dose |
| Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours | Ratio of whole blood, plasma [14C] PBT2 at 24 hours | 0 to 24 hours |
| Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last) | area under the plasma concentration vs time curve to the last timepoint | 0 to 72 hours |
| years |
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| Sex: Female, Male | 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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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Units | Counts |
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| Participants |
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| Primary | Mass Balance | Amount excreted as a percentage of the administered dose (%Ae) | PK Population | Posted | Geometric Mean | Standard Deviation | percentage of administered dose | 168 h (7 days) post dose |
|
|
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| Secondary | IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last) | Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 . | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/ml | 0 to 72 h post oral dose |
|
|
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| Secondary | Oral PK Profile of PBT2 as Assessed by AUC(0-last) | Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 . | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/ml | 72 h post oral dose |
|
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| Secondary | Safety and Tolerability of PBT2 | As assessed by the number of participants with adverse events | Safety Population | Posted | Number | participants | 72 h post oral dose |
|
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| Secondary | Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours | Ratio of whole blood, plasma [14C] PBT2 at 24 hours | PK population | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio [14C] PBT2 | 0 to 24 hours |
|
|
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| Secondary | Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last) | area under the plasma concentration vs time curve to the last timepoint | PK Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0 to 72 hours |
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| 0 |
| 6 |
| 1 |
| 6 |
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