Trial Outcomes & Findings for Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2 (NCT NCT02107313)
NCT ID: NCT02107313
Last Updated: 2016-03-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
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
Results posted on
2016-03-30
Participant Flow
Participants were screened and enrolled at 1 site in Australia
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
One participant did not do the FED cohor
|
0
|
1
|
Baseline Characteristics
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
Baseline characteristics by cohort
| Measure |
All Study Participants
n=18 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.
|
|---|---|
|
Age, Continuous
|
25.7 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 dosePopulation: PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters.
Outcome measures
| Measure |
Fed Cohort
n=18 Participants
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.
|
Fasted Cohort
n=17 Participants
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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|---|---|---|
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Area Under the Concentration-Time Curve (AUC 0-t)
|
1490.0 h*ng/mL
Standard Deviation 542.0
|
1273.0 h*ng/mL
Standard Deviation 552.3
|
SECONDARY outcome
Timeframe: Up to 15 days after the first dose of PBT2Population: Safety Population, as defined as all participants who received at least one dose of study drug
Outcome measures
| Measure |
Fed Cohort
n=18 Participants
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.
|
Fasted Cohort
n=17 Participants
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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|---|---|---|
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Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events
|
6 participants
|
2 participants
|
Adverse Events
Fed Cohort
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Fasted Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fed Cohort
n=17 participants at risk
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.
|
Fasted Cohort
n=18 participants at risk
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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|---|---|---|
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Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
0.00%
0/18 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
0.00%
0/18 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
|
Nervous system disorders
Disturbance in attention
|
5.9%
1/17 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
0.00%
0/18 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
0.00%
0/18 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
0.00%
0/18 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
|
Nervous system disorders
Migraine
|
0.00%
0/17 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
5.6%
1/18 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
5.6%
1/18 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
|
Vascular disorders
Phlebitis
|
5.9%
1/17 • Number of events 1 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
0.00%
0/18 • All adverse events reported from time of consent to end of study (Day 15, which was 8 days since last dose of PBT2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60