Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]IDV184001AN
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 by Indivior Pharmaceuticals, Inc. (ticker INDV) for opioid use disorder. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not approved for any use.
IDV184001AN is being developed for the treatment of opioid use disorder, a psychiatry indication. The clinical work completed to date studied the drug in healthy adult male participants rather than in patients with opioid use disorder, so its use in that condition remains investigational.
IDV184001AN is being developed by Indivior Pharmaceuticals, Inc., which trades under the ticker INDV. Indivior is the sponsor of the clinical program for this investigational small molecule in opioid use disorder.
IDV184001AN is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for opioid use disorder or any other indication.
IDV184001AN has been studied in one completed Phase 1 trial, NCT05974046, titled a single dose study of [14C]-IDV184001AN in healthy adult male participants. It enrolled 7 participants in the United States, was uncontrolled, and was not randomized or double blinded.
Yes. [14C]IDV184001AN is an alternative name for IDV184001AN. The carbon-14 label refers to the radiolabeled form used in the completed Phase 1 single dose study, NCT05974046, which was conducted in healthy adult male participants.