Trial Outcomes & Findings for Ultralow Dose PAH Binary Mixture Study (NCT NCT03631667)
NCT ID: NCT03631667
Last Updated: 2025-05-22
Results Overview
Determination of highest concentration of 14C-BaP 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 Cmax.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cycles
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
\[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
\[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Ultralow Dose PAH Binary Mixture Study
Baseline characteristics by cohort
| Measure |
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
n=8 Participants
Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene. At least 3 weeks must pass between each capsule dose administration.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
\[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cyclesDetermination of highest concentration of 14C-BaP 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 Cmax.
Outcome measures
| Measure |
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
n=5 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
\[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene
|
|---|---|
|
Peak Plasma Concentration of 14C-BaP Cmax
50 ng [14C]-BaP
|
7.07 fg [14C]-BaP/mL plasma
Standard Deviation 4.89
|
|
Peak Plasma Concentration of 14C-BaP Cmax
50 ng [14C]-BaP plus 1250 ng phenanthrene
|
1.60 fg [14C]-BaP/mL plasma
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: 0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cyclesDetermination of time at which plasma concentration of 14C-BaP 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.
Outcome measures
| Measure |
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
n=5 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
\[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene
|
|---|---|
|
Time at Highest Plasma Concentration of 14C-BaP Tmax
50 ng [14C]-BaP
|
1.1 hour
Standard Deviation 1.1
|
|
Time at Highest Plasma Concentration of 14C-BaP Tmax
50 ng [14C]-BaP plus 1250 ng phenanthrene
|
1.7 hour
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cyclesIntegration of concentration of 14C-BaP in plasma 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 |
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
n=5 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
\[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene
|
|---|---|
|
Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC
50 ng [14C]-BaP
|
17.88 fg [14C]-BaP/mL plasma x hour
Standard Deviation 9.56
|
|
Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC
50 ng [14C]-BaP plus 1250 ng phenanthrene
|
10.07 fg [14C]-BaP/mL plasma x hour
Standard Deviation 9.32
|
SECONDARY outcome
Timeframe: 0-48 hours for each of 2 dosing cycles, with a washout period of 3 weeks between the dosing cyclesDetermination of constants for rate of elimination of 14C-BaP 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 half-life.
Outcome measures
| Measure |
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
n=5 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP) and 1250 phenanthrene.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
\[14C\]-benzo\[a\]pyrene plus phenanthrene: Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene
|
|---|---|
|
Rate of Elimination of 14C-BaP (Half Life)
50 ng [14C]-BaP
|
4.78 hour
Standard Deviation 4.45
|
|
Rate of Elimination of 14C-BaP (Half Life)
50 ng [14C]-BaP plus 1250 ng phenanthrene
|
3.92 hour
Standard Deviation 4.12
|
Adverse Events
50 ng Dose and 50 ng Dose Plus 1250 ng Phenanthrene
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