Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDV184001AN · 1 trial · 1 indication
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...
IDV184001AN is an investigational small molecule being developed for the treatment of Opioid Use Disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential role in addressing this psychiatric condition.
IDV184001AN is being developed by Indivior Pharmaceuticals, Inc., a company listed on the stock exchange under the ticker symbol INDV. The company is conducting clinical research on this investigational drug for Opioid Use Disorder.
IDV184001AN is currently in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for the treatment of Opioid Use Disorder, and its safety and pharmacokinetics are being evaluated in early-stage trials.
IDV184001AN has one completed clinical trial registered under NCT05974046, titled "Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants." This Phase 1 study enrolled 7 healthy male participants in the United States and was an uncontrolled, open-label trial.
The specific molecular target or mechanism of action for IDV184001AN has not been disclosed in available information. The drug is a small molecule being investigated for Opioid Use Disorder, but its precise pharmacological action remains under study in clinical trials.