Healthy Volunteers
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFed Cohort PBT2
PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
DRUGFasted Cohort PBT2
PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food
Sponsors
Prana Biotechnology Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or females with a BMI between 19 and 30kg/m2 * No clinically significant abnormalities
Exclusion criteria
* Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2) * Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study entry * Significant history of depression or other psychiatric illness * Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion * unable to swallow capsules
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
Australia
Participant flow
Recruitment details
Participants were screened and enrolled at 1 site in Australia
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | One participant did not do the FED cohor | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 25.7 years STANDARD_DEVIATION 3.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment Australia | 18 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 17 | 2 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Area Under the Concentration-Time Curve (AUC 0-t)
Time frame: 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
Population: PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fed Cohort | Area Under the Concentration-Time Curve (AUC 0-t) | 1490.0 h*ng/mL | Standard Deviation 542 |
| Fasted Cohort | Area Under the Concentration-Time Curve (AUC 0-t) | 1273.0 h*ng/mL | Standard Deviation 552.3 |
Secondary
Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events
Time frame: Up to 15 days after the first dose of PBT2
Population: Safety Population, as defined as all participants who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fed Cohort | Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events | 6 participants |
| Fasted Cohort | Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events | 2 participants |