Healthy Volunteers
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPBT2
PBT2 250 mg administered
Sponsors
Prana Biotechnology Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males 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 * 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 or tablets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg | 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. | 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. |
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 Event | Up to 19 days after first dose of caffeine |
Countries
Australia
Participant flow
Recruitment details
Participants were screened and enrolled at one study site in Australia
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Caffeine Dosing |
|---|---|
| Age, Continuous | 25.6 years STANDARD_DEVIATION 5.5 |
| BMI | 24.05 kg/m^2 STANDARD_DEVIATION 2.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 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 | 16 Participants |
| Region of Enrollment Australia | 18 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine Dosing | Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg | 32775 ng*hr/mL | Standard Deviation 11552 |
Secondary
Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event
Time frame: Up to 19 days after first dose of caffeine
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caffeine Dosing | Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event | 7 participants |