Trial Outcomes & Findings for Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants (NCT NCT05974046)
NCT ID: NCT05974046
Last Updated: 2025-02-13
Results Overview
Percentage of total radioactivity recovered relative to dose (%Dose) in urine, feces and urine + feces (by time interval)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
Pre-dose to 168 hours post-dose
Results posted on
2025-02-13
Participant Flow
Participant milestones
| Measure |
Treatment
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
Baseline characteristics by cohort
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 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
|
0 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
|
7 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
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-dosePercentage of total radioactivity recovered relative to dose (%Dose) in urine, feces and urine + feces (by time interval)
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 0-4 hours post dose
|
19.0 Percentage of dose
Geometric Coefficient of Variation 25.9
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 4-8 hours post dose
|
25.3 Percentage of dose
Geometric Coefficient of Variation 11.6
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 8-12 hours post dose
|
13.1 Percentage of dose
Geometric Coefficient of Variation 18.2
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 12-24 hours post dose
|
13.5 Percentage of dose
Geometric Coefficient of Variation 39.3
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 24-48 hours post dose
|
5.04 Percentage of dose
Geometric Coefficient of Variation 48.6
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 48-72 hours post dose
|
0.941 Percentage of dose
Geometric Coefficient of Variation 58.0
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 72-96 hours post dose
|
0.304 Percentage of dose
Geometric Coefficient of Variation 55.0
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 96-120 hours post dose
|
0.150 Percentage of dose
Geometric Coefficient of Variation 45.8
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 120-144 hours post dose
|
0.0919 Percentage of dose
Geometric Coefficient of Variation 39.0
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 144-168 hours post dose
|
0.0585 Percentage of dose
Geometric Coefficient of Variation 24.4
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 0-24 hours post dose
|
3.28 Percentage of dose
Geometric Coefficient of Variation 6561.3
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 24-48 hours post dose
|
1.91 Percentage of dose
Geometric Coefficient of Variation 707.0
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 48-72 hours post dose
|
0.892 Percentage of dose
Geometric Coefficient of Variation 576.5
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 72-96 hours post dose
|
4.16 Percentage of dose
Geometric Coefficient of Variation 380.2
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 96-120 hours post dose
|
1.16 Percentage of dose
Geometric Coefficient of Variation 256.0
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 120-144 hours post dose
|
0.606 Percentage of dose
Geometric Coefficient of Variation 303.4
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 144-168 hours post dose
|
0.292 Percentage of dose
Geometric Coefficient of Variation 59.6
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 0-4 hours post dose
|
19.0 Percentage of dose
Geometric Coefficient of Variation 25.9
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 4-8 hours post dose
|
25.3 Percentage of dose
Geometric Coefficient of Variation 11.6
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 8-12 hours post dose
|
13.1 Percentage of dose
Geometric Coefficient of Variation 18.2
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 12-24 hours post dose
|
18.3 Percentage of dose
Geometric Coefficient of Variation 37.2
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 24-48 hours post dose
|
9.04 Percentage of dose
Geometric Coefficient of Variation 70.6
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 48-72 hours post dose
|
1.87 Percentage of dose
Geometric Coefficient of Variation 94.0
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 72-96 hours post dose
|
2.16 Percentage of dose
Geometric Coefficient of Variation 534.2
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 96-120 hours post dose
|
1.34 Percentage of dose
Geometric Coefficient of Variation 211.9
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 120-144 hours post dose
|
0.629 Percentage of dose
Geometric Coefficient of Variation 313.7
|
|
Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces, 144-168 hours post dose
|
0.318 Percentage of dose
Geometric Coefficient of Variation 63.2
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-dosePercentage of cumulative total radioactivity recovered relative to dose (Cum%Dose) in urine, feces, and urine+feces (0-168 hours)
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Cumulative Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (Cum%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine
|
79.7 Percent dose
Standard Deviation 5.769
|
|
Cumulative Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (Cum%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces
|
21.1 Percent dose
Standard Deviation 5.342
|
|
Cumulative Percent of Radioactive Dose Excreted in the Urine, Feces, and Urine+Feces (Cum%Dose) Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+Feces
|
101 Percent dose
Standard Deviation 0.6258
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: AUC\[last\] (area under the concentration-time curve from time 0 to the time of the last quantifiable concentration calculated using the linear trapezoidal rule) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity AUClast in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
77300 ngEq*h/mL
Geometric Coefficient of Variation 32.6
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: AUC\[last\] (area under the concentration-time curve from time 0 to the time of the last quantifiable concentration calculated using the linear trapezoidal rule) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity AUClast in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
37700 ngEq*h/g
Geometric Coefficient of Variation 31.7
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: AUC\[0-∞\] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity AUC[0-∞] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
83000 ngEq*h/mL
Geometric Coefficient of Variation 33.4
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: AUC\[0-∞\] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity AUC[0-∞] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
40100 ngEq*h/g
Geometric Coefficient of Variation 30.2
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: AUC\[extrap(%)\] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
6.84 Percentage of AUC extrapolated
Geometric Coefficient of Variation 17.4
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: AUC\[extrap(%)\] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity AUC[Extrap(%)] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
5.60 Percentage of AUC extrapolated
Geometric Coefficient of Variation 30.3
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: Cmax (maximum observed concentration) as data permit. The Units of Measure for Cmax (i.e., " ngEq/mL") reflect the peak concentration that occurred from pre-dose to 168 hours post-dose.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity Cmax in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
6800 ngEq/mL
Geometric Coefficient of Variation 16.5
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: Cmax (maximum observed concentration) as data permit. The Units of Measure for Cmax (i.e., " ngEq/g)") reflect the peak concentration that occurred from pre-dose to 168 hours post-dose.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity Cmax in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
3980 ngEq/g
Geometric Coefficient of Variation 16.1
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: Tmax (time of Cmax) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity Tmax in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Plasma
|
2.01 hour
Geometric Coefficient of Variation 52.2
|
|
Total Radioactivity Tmax in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Whole blood
|
1.94 hour
Geometric Coefficient of Variation 44.3
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: λz (terminal phase rate constant) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity λz in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Plasma
|
0.0180 1/hour
Geometric Coefficient of Variation 63.5
|
|
Total Radioactivity λz in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Whole blood
|
0.0775 1/hour
Geometric Coefficient of Variation 46.3
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseAe\[t1-t2\] (amount of total radioactivity excreted/recovered in urine, feces, and urine+feces within a given collection interval)
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 0-4 hour post dose
|
38.8 mgEq
Geometric Coefficient of Variation 25.9
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 4-8 hour post dose
|
51.7 mgEq
Geometric Coefficient of Variation 11.7
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 8-12 hour post dose
|
26.8 mgEq
Geometric Coefficient of Variation 18.2
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 12-24 hour post dose
|
27.6 mgEq
Geometric Coefficient of Variation 39.3
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 24-48 hour post dose
|
10.3 mgEq
Geometric Coefficient of Variation 48.5
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 48-72 hour post dose
|
1.92 mgEq
Geometric Coefficient of Variation 58.0
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 72-96 hour post dose
|
0.620 mgEq
Geometric Coefficient of Variation 55.0
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 96-120 hour post dose
|
0.306 mgEq
Geometric Coefficient of Variation 45.6
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 120-144 hour post dose
|
0.188 mgEq
Geometric Coefficient of Variation 38.8
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine, 144-168 hour post dose
|
0.119 mgEq
Geometric Coefficient of Variation 24.3
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 0-24 hour post dose
|
6.69 mgEq
Geometric Coefficient of Variation 6587.9
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 24-48 hour post dose
|
3.89 mgEq
Geometric Coefficient of Variation 707.2
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 48-72 hour post dose
|
1.82 mgEq
Geometric Coefficient of Variation 575.4
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 72-96 hour post dose
|
8.50 mgEq
Geometric Coefficient of Variation 380.8
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 96-120 hour post dose
|
2.37 mgEq
Geometric Coefficient of Variation 255.7
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 120-144 hour post dose
|
1.24 mgEq
Geometric Coefficient of Variation 303.9
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces, 144-168 hour post dose
|
0.597 mgEq
Geometric Coefficient of Variation 59.5
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 0-4 hour post dose
|
38.8 mgEq
Geometric Coefficient of Variation 25.9
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 4-8 hour post dose
|
51.7 mgEq
Geometric Coefficient of Variation 11.7
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 8-12 hour post dose
|
26.8 mgEq
Geometric Coefficient of Variation 18.2
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 12-24 hour post dose
|
37.3 mgEq
Geometric Coefficient of Variation 37.3
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 24-48 hour post dose
|
18.5 mgEq
Geometric Coefficient of Variation 70.4
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 48-72 hour post dose
|
3.82 mgEq
Geometric Coefficient of Variation 93.9
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 72-96 hour post dose
|
4.42 mgEq
Geometric Coefficient of Variation 535.1
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 96-120 hour post dose
|
2.74 mgEq
Geometric Coefficient of Variation 211.6
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 120-144 hour post dose
|
1.28 mgEq
Geometric Coefficient of Variation 314.2
|
|
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces, 144-168 hour post dose
|
0.649 mgEq
Geometric Coefficient of Variation 63.1
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTotal radioactivity pharmacokinetic parameter: T1/2 (apparent terminal half-life) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity T1/2 in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Plasma
|
38.5 hour
Geometric Coefficient of Variation 63.5
|
|
Total Radioactivity T1/2 in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Whole blood
|
8.94 hour
Geometric Coefficient of Variation 46.3
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseCumAe (cumulative amount of total radioactivity excreted/recovered in urine, feces, and urine+feces) (0-168 hour)
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity CumAe in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine
|
162 mgEq
Geometric Coefficient of Variation 7.4
|
|
Total Radioactivity CumAe in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Feces
|
41.9 mgEq
Geometric Coefficient of Variation 26.1
|
|
Total Radioactivity CumAe in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Urine+feces
|
206 mgEq
Geometric Coefficient of Variation 0.7
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseCLr (renal clearance)
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Total Radioactivity CLr in Urine Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
|
2.10 L/hour
Geometric Coefficient of Variation 29.9
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseAUC\[last\] (area under the concentration-time curve from time 0 to the time of the last quantifiable concentration calculated using the linear trapezoidal rule) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Unlabeled IDV184001 and M12 AUC[Last] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled IDV184001 plasma
|
7150 ng*h/mL
Geometric Coefficient of Variation 38.2
|
|
Unlabeled IDV184001 and M12 AUC[Last] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled M12 plasma
|
8940 ng*h/mL
Geometric Coefficient of Variation 50.8
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseAUC\[0-∞\] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Unlabeled IDV184001 and M12 AUC[0-∞] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled IDV184001 in plasma
|
7250 ng*h/mL
Geometric Coefficient of Variation 37.3
|
|
Unlabeled IDV184001 and M12 AUC[0-∞] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled M12 in plasma
|
9070 ng*h/mL
Geometric Coefficient of Variation 50.5
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseAUC\[extrap(%)\] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Unlabeled IDV184001 and M12 AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled IDV184001 in plasma
|
0.775 Percentage of AUC extrapolated
Geometric Coefficient of Variation 184.2
|
|
Unlabeled IDV184001 and M12 AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled M12 in plasma
|
1.08 Percentage of AUC extrapolated
Geometric Coefficient of Variation 108.7
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseCmax (maximum observed concentration) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Unlabeled IDV184001 and M12 Cmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled M12 in plasma
|
1140 ng/mL
Geometric Coefficient of Variation 32.0
|
|
Unlabeled IDV184001 and M12 Cmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled IDV184001 in plasma
|
1380 ng/mL
Geometric Coefficient of Variation 30.0
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseTmax (time of Cmax) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Unlabeled IDV184001 and M12 Tmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled IDV184001 in plasma
|
1.43 hour
Geometric Coefficient of Variation 73.3
|
|
Unlabeled IDV184001 and M12 Tmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled M12 in plasma
|
2.29 hour
Geometric Coefficient of Variation 48.3
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseλz (terminal phase rate constant) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Unlabeled IDV184001 and M12 λz in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled IDV184001 in plasma
|
0.277 1/hour
Geometric Coefficient of Variation 21.0
|
|
Unlabeled IDV184001 and M12 λz in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled M12 in plasma
|
0.172 1/hour
Geometric Coefficient of Variation 21.2
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseT1/2 (apparent terminal half-life) as data permit.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Unlabeled IDV184001 and M12 T1/2 in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled IDV184001 in plasma
|
2.50 hour
Geometric Coefficient of Variation 21.0
|
|
Unlabeled IDV184001 and M12 T1/2 in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Unlabeled M12 in plasma
|
4.02 hour
Geometric Coefficient of Variation 21.2
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseRatio of unlabeled IDV184001 and M12 in plasma to plasma total radioactivity for AUC\[last\] (area under the concentration-time curve from time 0 to the time of the last quantifiable concentration calculated using the linear trapezoidal rule), where appropriate
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Ratio of Unlabeled IDV184001 and M12 in Plasma to Plasma Total Radioactivity for AUC[Last] Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
IDV184001
|
0.0926 Ratio in plasma
Geometric Coefficient of Variation 14.7
|
|
Ratio of Unlabeled IDV184001 and M12 in Plasma to Plasma Total Radioactivity for AUC[Last] Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M12
|
0.120 Ratio in plasma
Geometric Coefficient of Variation 21.9
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseRatio of unlabeled IDV184001 and M12 in plasma to plasma total radioactivity for Cmax (maximum observed concentration), where appropriate
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Ratio of Unlabeled IDV184001 and M12 in Plasma to Plasma Total Radioactivity for Cmax Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
IDV184001
|
0.202 Ratio in plasma
Geometric Coefficient of Variation 16.5
|
|
Ratio of Unlabeled IDV184001 and M12 in Plasma to Plasma Total Radioactivity for Cmax Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M12
|
0.173 Ratio in plasma
Geometric Coefficient of Variation 21.2
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseDetermination of percentage of AUC (area under the concentration-time curve) of each identified metabolites to total AUC in plasma
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M12
|
23.6 Percentage of AUC
|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
IDV184001
|
21.9 Percentage of AUC
|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M598 Isomer 1
|
15.5 Percentage of AUC
|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M422 Isomer 1
|
16.7 Percentage of AUC
|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M422 Isomer 2
|
13.7 Percentage of AUC
|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M275 Isomer 2
|
3.0 Percentage of AUC
|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M438
|
3.4 Percentage of AUC
|
|
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M436
|
2.2 Percentage of AUC
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseDetermination of percentage of dose of each identified metabolites in urine
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M598 Isomer 1
|
21.9 Percentage of dose
Interval 13.1 to 28.6
|
|
Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M436
|
8.2 Percentage of dose
Interval 6.1 to 11.4
|
|
Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M275 Isomer 2
|
6.7 Percentage of dose
Interval 5.4 to 8.3
|
|
Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M291, M275, and M289 Isomer 1
|
7.6 Percentage of dose
Interval 4.9 to 10.8
|
|
Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
M422 Isomer 1 and M628 Isomer 2
|
9.5 Percentage of dose
Interval 7.0 to 12.3
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseDetermination of percentage of AUC (area under the concentration-time curve) of M436 metabolite to total AUC in feces
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Percentage of Total AUC of Each Identified Metabolite in Feces Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
|
14.7 Percentage of AUC
Interval 9.5 to 19.9
|
PRIMARY outcome
Timeframe: Pre-dose to 168 hours post-doseThe ratio of total radioactivity concentration equivalents in whole blood relative to plasma at each time-matched determination of total radioactivity in whole blood and plasma
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
30 minutes post dose
|
0.571 ml/g
Standard Deviation 0.06012
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
1 hour post dose
|
0.567 ml/g
Standard Deviation 0.04071
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
2 hours post dose
|
0.584 ml/g
Standard Deviation 0.02070
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
3 hours post dose
|
0.574 ml/g
Standard Deviation 0.02637
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
4 hours post dose
|
0.564 ml/g
Standard Deviation 0.01618
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
6 hours post dose
|
0.574 ml/g
Standard Deviation 0.02699
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
8 hours post dose
|
0.561 ml/g
Standard Deviation 0.05815
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
12 hours post dose
|
0.573 ml/g
Standard Deviation 0.03147
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
24 hours post dose
|
0.543 ml/g
Standard Deviation 0.03200
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
48 hours post dose
|
0.219 ml/g
Standard Deviation 0.2734
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
72 hours post dose
|
0.0750 ml/g
Standard Deviation 0.1837
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
96 hours post dose
|
0 ml/g
Standard Deviation 0
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
120 hours post dose
|
NA ml/g
Standard Deviation NA
Not applicable as concentration was below the lower limit of quantification
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
144 hours post dose
|
NA ml/g
Standard Deviation NA
Not applicable as concentration was below the lower limit of quantification
|
|
Determination of the Ratio of Total Radioactivity Concentration Equivalents in Whole Blood Versus Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
168 hours post dose
|
NA ml/g
Standard Deviation NA
Not applicable as concentration was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: From informed consent signature to end of study (up to 11 days)Population: Based on Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Potentially life-threatening.
Incidence, seriousness, severity, and relatedness of treatment-emergent adverse events.
Outcome measures
| Measure |
Treatment
n=7 Participants
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Any TEAE
|
1 Participants
|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Serious
|
0 Participants
|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Study-drug related
|
1 Participants
|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Serious and study drug-related
|
0 Participants
|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Severe
|
0 Participants
|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Toxicity Grade >= 3
|
0 Participants
|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Resulted in study discontinuation
|
0 Participants
|
|
Assessment of the Safety and Tolerability (Incidence, Seriousness, Severity, and Relatedness of Treatment-emergent Adverse Events) of a Single Oral Dose of [14C] IDV184001AN as Determined by Adverse Event Reporting
Resulted in death
|
0 Participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=7 participants at risk
\[14C\]IDV184001AN
\[14C\]IDV184001AN: \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension
|
|---|---|
|
Eye disorders
LACRIMATION INCREASED
|
14.3%
1/7 • From informed consent signature to end of study (up to 11 days).
|
|
Eye disorders
PHOTOPHOBIA
|
14.3%
1/7 • From informed consent signature to end of study (up to 11 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place