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This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of caffeine and the effects that PBT2 has on the metabolism of caffeine in healthy volunteers.
This study will be conducted with all participants receiving a dose of caffeine 100 mg on Day 1 followed by a 7 day washout period before commencing 5 consecutive days of PBT2 250 mg from Day 8 to 12 and a second dose of caffeine 100 mg on Day 12. Pharmacokinetic samples will be collected during after each dose of the study drugs, along with safety monitoring assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine Dosing | Other | Single dose of caffeine 100 mg administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBT2 | Drug | PBT2 250 mg administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg | PK Per Protocol Population, as defined as all participants who received scheduled doses of both caffeine and PBT2 and had sufficient samples collected to determine PK parameters from plasma concentrations of caffeine on Day 1 and Day 12. | prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 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 Event | Up to 19 days after first dose of caffeine |
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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 one study site in Australia
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| ID | Title | Description |
|---|---|---|
| FG000 | Caffeine Dosing | Single dose of caffeine 100 mg administered on Day 1 and Day 12 with PBT2 250 mg administered from Day 8 to 12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caffeine Dosing | Single dose of caffeine 100 mg administered on Day 1 and Day 12 PBT2: PBT2 250 mg administered is Day 8 to 12. |
| 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 Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg | PK Per Protocol Population, as defined as all participants who received scheduled doses of both caffeine and PBT2 and had sufficient samples collected to determine PK parameters from plasma concentrations of caffeine on Day 1 and Day 12. | Posted | Mean | Standard Deviation | ng*hr/mL | prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 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 19, which was 7 days since last dose of both caffeine and 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 | Caffeine Dosing | Single dose of caffeine 100 mg administered on Day 1 and Day 12 PBT2: PBT2 250 mg administered is Day 8 to 12. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Caroline Herd | Prana Biotechnology | +6133494906 | info@pranabio.com |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Secondary | Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event | Safety population | Posted | Number | participants | Up to 19 days after first dose of caffeine |
|
|
|
| 0 |
| 18 |
| 7 |
| 18 |
| Carbuncle | Infections and infestations | MedDRA 16.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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