Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05974046 | Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants | PHASE1 | COMPLETED | 7 | — | — | Jul 10, 2023 | Jul 21, 2023 | Feb 13, 2025 | 1 | United States |
Percentage of total radioactivity recovered relative to dose (%Dose) in urine, feces and urine + feces (by time interval)
Percentage of cumulative total radioactivity recovered relative to dose (Cum%Dose) in urine, feces, and urine+feces (0-168 hours)
Total 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.
Total 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.
Total radioactivity pharmacokinetic parameter: AUC\[0-∞\] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Total radioactivity pharmacokinetic parameter: AUC\[0-∞\] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Total radioactivity pharmacokinetic parameter: AUC\[extrap(%)\] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Total radioactivity pharmacokinetic parameter: AUC\[extrap(%)\] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Total 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.
Total 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.
Total radioactivity pharmacokinetic parameter: Tmax (time of Cmax) as data permit.
Total radioactivity pharmacokinetic parameter: λz (terminal phase rate constant) as data permit.
Ae\[t1-t2\] (amount of total radioactivity excreted/recovered in urine, feces, and urine+feces within a given collection interval)
Total radioactivity pharmacokinetic parameter: T1/2 (apparent terminal half-life) as data permit.
CumAe (cumulative amount of total radioactivity excreted/recovered in urine, feces, and urine+feces) (0-168 hour)
CLr (renal clearance)
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.
AUC\[0-∞\] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
AUC\[extrap(%)\] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Cmax (maximum observed concentration) as data permit.
Tmax (time of Cmax) as data permit.
λz (terminal phase rate constant) as data permit.
T1/2 (apparent terminal half-life) as data permit.
Ratio 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
Ratio of unlabeled IDV184001 and M12 in plasma to plasma total radioactivity for Cmax (maximum observed concentration), where appropriate
Determination of percentage of AUC (area under the concentration-time curve) of each identified metabolites to total AUC in plasma
Determination of percentage of dose of each identified metabolites in urine
Determination of percentage of AUC (area under the concentration-time curve) of M436 metabolite to total AUC in feces
The 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
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | \[14C\]IDV184001AN |
| Name | Type | Description |
|---|---|---|
| [14C]IDV184001AN | DRUG | \[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension |
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be 19 to 55 years of age inclusive, at the time of signing the informed consent. 2. Participant must have body weight of a minimum of 50.0 kg at the Scre...