Trial Outcomes & Findings for Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine (NCT NCT02109497)
NCT ID: NCT02109497
Last Updated: 2016-04-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
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.
Results posted on
2016-04-29
Participant Flow
Participants were screened and enrolled at one study site in Australia
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Study to Determine the Effects of PBT2 on the Pharmacokinetic Profile of Caffeine
Baseline characteristics by cohort
| Measure |
Caffeine Dosing
n=18 Participants
Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12.
|
|---|---|
|
Age, Continuous
|
25.6 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 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
|
2 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
|
16 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
|
|
BMI
|
24.05 kg/m^2
STANDARD_DEVIATION 2.46 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Caffeine Dosing
n=17 Participants
Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12.
|
|---|---|
|
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 outcome
Timeframe: Up to 19 days after first dose of caffeinePopulation: Safety population
Outcome measures
| Measure |
Caffeine Dosing
n=18 Participants
Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12.
|
|---|---|
|
Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event
|
7 participants
|
Adverse Events
Caffeine Dosing
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caffeine Dosing
n=18 participants at risk
Single dose of caffeine 100 mg administered on Day 1 and Day 12
PBT2: PBT2 250 mg administered is Day 8 to 12.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • 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).
|
|
Infections and infestations
Carbuncle
|
5.6%
1/18 • Number of events 1 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 1 • 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).
|
|
Nervous system disorders
Disturbance in attention
|
11.1%
2/18 • Number of events 2 • 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).
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • 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).
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • Number of events 1 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60