Trial Outcomes & Findings for Benzo[a]Pyrene Ultralow Dose-Response Study (NCT NCT03318978)
NCT ID: NCT03318978
Last Updated: 2025-05-22
Results Overview
Determination of highest concentration in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine peak plasma concentration Cmax.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose
\[14C\]-benzo\[a\]pyrene: Oral micro-dose range (25, 50, 100 and 250 ng)
At least 3 weeks must pass between each capsule dose administration.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose
\[14C\]-benzo\[a\]pyrene: Oral micro-dose range (25, 50, 100 and 250 ng)
At least 3 weeks must pass between each capsule dose administration.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Benzo[a]Pyrene Ultralow Dose-Response Study
Baseline characteristics by cohort
| Measure |
25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose
n=8 Participants
\[14C\]-benzo\[a\]pyrene: Oral micro-dose range (25, 50, 100 and 250 ng)
At least 3 weeks must pass between each capsule dose administration.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycleDetermination of highest concentration in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine peak plasma concentration Cmax.
Outcome measures
| Measure |
25 ng, 50 ng, 100 ng, and 250 ng Doses
n=7 Participants
Cycle 1: Capsule containing 25 ng \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 3: Capsule containing 100 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 4: Capsule containing 250 ng \[14C\]-benzo\[a\]pyrene (BaP)
At least 3 weeks will pass between cycles as a washout period.
|
|---|---|
|
Peak Plasma Concentration Cmax
25 ng [14C]-BaP
|
2.51 fg [14C]-BaP/mL plasma
Standard Deviation 2.53
|
|
Peak Plasma Concentration Cmax
50 ng [14C]-BaP
|
5.68 fg [14C]-BaP/mL plasma
Standard Deviation 4.70
|
|
Peak Plasma Concentration Cmax
100 ng [14C]-BaP
|
13.8 fg [14C]-BaP/mL plasma
Standard Deviation 9.52
|
|
Peak Plasma Concentration Cmax
250 ng [14C]-BaP
|
8.99 fg [14C]-BaP/mL plasma
Standard Deviation 7.08
|
SECONDARY outcome
Timeframe: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycleDetermination of time at which plasma concentration is highest. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Tmax, time at highest plasma concentration.
Outcome measures
| Measure |
25 ng, 50 ng, 100 ng, and 250 ng Doses
n=7 Participants
Cycle 1: Capsule containing 25 ng \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 3: Capsule containing 100 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 4: Capsule containing 250 ng \[14C\]-benzo\[a\]pyrene (BaP)
At least 3 weeks will pass between cycles as a washout period.
|
|---|---|
|
Time at Highest Plasma Concentration Tmax
25 ng [14C]-BaP
|
0.5 hour
Interval 0.5 to 4.0
|
|
Time at Highest Plasma Concentration Tmax
50 ng [14C]-BaP
|
0.5 hour
Interval 0.5 to 1.0
|
|
Time at Highest Plasma Concentration Tmax
100 ng [14C]-BaP
|
0.5 hour
Interval 0.5 to 1.0
|
|
Time at Highest Plasma Concentration Tmax
250 ng [14C]-BaP
|
0.5 hour
Interval 0.5 to 3.0
|
SECONDARY outcome
Timeframe: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycleIntegration of concentration over time. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine AUC.
Outcome measures
| Measure |
25 ng, 50 ng, 100 ng, and 250 ng Doses
n=7 Participants
Cycle 1: Capsule containing 25 ng \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 3: Capsule containing 100 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 4: Capsule containing 250 ng \[14C\]-benzo\[a\]pyrene (BaP)
At least 3 weeks will pass between cycles as a washout period.
|
|---|---|
|
Area Under Plasma Concentration Versus Time Curve AUC
25 ng [14C]-BaP
|
12.2 fg [14C]-BaP/mL plasma x hour
Standard Deviation 14.5
|
|
Area Under Plasma Concentration Versus Time Curve AUC
50 ng [14C]-BaP
|
19.6 fg [14C]-BaP/mL plasma x hour
Standard Deviation 15.7
|
|
Area Under Plasma Concentration Versus Time Curve AUC
100 ng [14C]-BaP
|
88.5 fg [14C]-BaP/mL plasma x hour
Standard Deviation 14.1
|
|
Area Under Plasma Concentration Versus Time Curve AUC
250 ng [14C]-BaP
|
68.6 fg [14C]-BaP/mL plasma x hour
Standard Deviation 60.4
|
SECONDARY outcome
Timeframe: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycleDetermination of constants for rate of elimination from plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine k1e.
Outcome measures
| Measure |
25 ng, 50 ng, 100 ng, and 250 ng Doses
n=7 Participants
Cycle 1: Capsule containing 25 ng \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 3: Capsule containing 100 ng \[14C\]-benzo\[a\]pyrene (BaP)
Cycle 4: Capsule containing 250 ng \[14C\]-benzo\[a\]pyrene (BaP)
At least 3 weeks will pass between cycles as a washout period.
|
|---|---|
|
Rate of Elimination (k1e)
25 ng [14C]-BaP
|
12.2 hour(-1)
Standard Deviation 14.5
|
|
Rate of Elimination (k1e)
50 ng [14C]-BaP
|
19.6 hour(-1)
Standard Deviation 15.7
|
|
Rate of Elimination (k1e)
100 ng [14C]-BaP
|
88.5 hour(-1)
Standard Deviation 14.1
|
|
Rate of Elimination (k1e)
250 ng [14C]-BaP
|
68.6 hour(-1)
Standard Deviation 64.0
|
Adverse Events
25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place