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The purpose of this open label study is to characterise the absorption, metabolism, excretion, and mass balance of [14C]-IDV184001AN ([14C]-IDV184001) in healthy adult male participants.
The study is designed as an open label, single-dose study in healthy adult participants for the following reasons:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | [14C]IDV184001AN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]IDV184001AN | Drug | [14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Percentage of total radioactivity recovered relative to dose (%Dose) in urine, feces and urine + feces (by time interval) | Pre-dose to 168 hours post-dose |
| 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 | Percentage of cumulative total radioactivity recovered relative to dose (Cum%Dose) in urine, feces, and urine+feces (0-168 hours) | Pre-dose to 168 hours post-dose |
| Total Radioactivity AUClast in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Pre-dose to 168 hours post-dose |
| Total Radioactivity AUClast in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Pre-dose to 168 hours post-dose |
| Total Radioactivity AUC[0-∞] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Incidence, seriousness, severity, and relatedness of treatment-emergent adverse events. | From informed consent signature to end of study (up to 11 days) |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Have an ongoing medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, psychiatric or other disorder as judged by an Investigator that could potentially affect the study outcomes or compromise participant safety.
Have clinically significant abnormal biochemistry, haematology or urinalysis results as judged by an Investigator.
Have a history of narcolepsy or sleep apnea.
Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
Current active hepatic or biliary disease.
Participants with cholecystectomy <90 days prior to the Screening Visit.
Positive test results for HIV-1/HIV-2 antibodies, HBsAg or Hepatitis C antibodies at the Screening Visit.
Have a blood pressure reading outside of the following range: Systolic <86 or >149 mmHg; Diastolic <50 or >94 mmHg at the Screening Visit.
Serious cardiac illness or other medical condition including, but not limited to:
History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at the Screening Visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.
Healthy participants who are taking, or have taken, any prescribed or over the counter drugs (other than 2 grams of acetaminophen per 24-hour period as of Day 1 or thyroid hormone replacement therapy) or herbal remedies in the 14 days or 5 half-lives (whichever is longer) prior to dosing of study drug.
Treatment with any known drugs that are moderate or strong inhibitors/inducers of CYP3A4 or CYP2C19, including St. John's Wort, within 30 days prior to dosing of study drug.
Any consumption of food or drink containing poppy seeds, grapefruit or Seville oranges within 14 days prior to dosing of study drug.
Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
Positive test result for alcohol and/or drugs of abuse at the Screening Visit or at check-in.
Concurrent treatment or treatment with an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to dosing of study drug.
Blood donation of approximately 500 mL or more within 56 days or plasma donation within 7 days prior to the Screening Visit.
Known hypersensitivity to INDV-2000.
Has less than 1 bowel movement every 2 days.
Recent history of abnormal bowel movements, such as diarrhea, loose stools or constipation, within 2 weeks prior to dosing of study drug.
Has received radiolabelled substances or has been exposed to radiation sources over the past 12 months or is likely to receive radiation exposure or radioisotopes within the next 12 months such that participation in this study would increase their total exposure beyond the recommended levels considered safe (ie, weighted annual limit recommended by the FDA 21CFR361 of 3000 mrem; FDA 2023).
Site staff and/or participants who have a financial interest in, or an immediate family member of either the site staff and/or Indivior employees, directly involved in the study.
Major surgical procedure (as defined by the Investigator) within 90 days prior to dosing of study drug or still recovering from prior surgery.
Concurrent enrolment in another clinical study, unless it is an observational study.
Participants who are unable, in the opinion of the Investigator, to comply fully with the study requirements.
Any condition that, in the opinion of the Investigator or Indivior, would interfere with evaluation of the study drug or interpretation of participant safety or study results.
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| Name | Affiliation | Role |
|---|---|---|
| Global Director Clinical Development | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | [14C]IDV184001AN [14C]IDV184001AN: [14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | [14C]IDV184001AN [14C]IDV184001AN: [14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Percentage of total radioactivity recovered relative to dose (%Dose) in urine, feces and urine + feces (by time interval) | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of dose | Pre-dose to 168 hours post-dose |
|
|
From informed consent signature to end of study (up to 11 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | [14C]IDV184001AN [14C]IDV184001AN: [14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LACRIMATION INCREASED | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Director | Clinical Development | (804) 594-4488 | trialdisclosure@indivior.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2023 | Jul 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2023 | Jul 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Pre-dose to 168 hours post-dose |
| Total Radioactivity AUC[0-∞] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit. | Pre-dose to 168 hours post-dose |
| Total Radioactivity AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit. | Pre-dose to 168 hours post-dose |
| Total Radioactivity AUC[Extrap(%)] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit. | Pre-dose to 168 hours post-dose |
| Total Radioactivity Cmax in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Pre-dose to 168 hours post-dose |
| Total Radioactivity Cmax in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Pre-dose to 168 hours post-dose |
| Total Radioactivity Tmax in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: Tmax (time of Cmax) as data permit. | Pre-dose to 168 hours post-dose |
| Total Radioactivity λz in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: λz (terminal phase rate constant) as data permit. | Pre-dose to 168 hours post-dose |
| Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Ae[t1-t2] (amount of total radioactivity excreted/recovered in urine, feces, and urine+feces within a given collection interval) | Pre-dose to 168 hours post-dose |
| Total Radioactivity T1/2 in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: T1/2 (apparent terminal half-life) as data permit. | Pre-dose to 168 hours post-dose |
| Total Radioactivity CumAe in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | CumAe (cumulative amount of total radioactivity excreted/recovered in urine, feces, and urine+feces) (0-168 hour) | Pre-dose to 168 hours post-dose |
| Total Radioactivity CLr in Urine Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | CLr (renal clearance) | Pre-dose to 168 hours post-dose |
| Unlabeled IDV184001 and M12 AUC[Last] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | 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. | Pre-dose to 168 hours post-dose |
| Unlabeled IDV184001 and M12 AUC[0-∞] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit. | Pre-dose to 168 hours post-dose |
| Unlabeled IDV184001 and M12 AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit. | Pre-dose to 168 hours post-dose |
| Unlabeled IDV184001 and M12 Cmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Cmax (maximum observed concentration) as data permit. | Pre-dose to 168 hours post-dose |
| Unlabeled IDV184001 and M12 Tmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Tmax (time of Cmax) as data permit. | Pre-dose to 168 hours post-dose |
| Unlabeled IDV184001 and M12 λz in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | λz (terminal phase rate constant) as data permit. | Pre-dose to 168 hours post-dose |
| Unlabeled IDV184001 and M12 T1/2 in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | T1/2 (apparent terminal half-life) as data permit. | Pre-dose to 168 hours post-dose |
| 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 | 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 | Pre-dose to 168 hours post-dose |
| 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 | Ratio of unlabeled IDV184001 and M12 in plasma to plasma total radioactivity for Cmax (maximum observed concentration), where appropriate | Pre-dose to 168 hours post-dose |
| Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Determination of percentage of AUC (area under the concentration-time curve) of each identified metabolites to total AUC in plasma | Pre-dose to 168 hours post-dose |
| Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Determination of percentage of dose of each identified metabolites in urine | Pre-dose to 168 hours post-dose |
| Percentage of Total AUC of Each Identified Metabolite in Feces Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Determination of percentage of AUC (area under the concentration-time curve) of M436 metabolite to total AUC in feces | Pre-dose to 168 hours post-dose |
| 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 | 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 | Pre-dose to 168 hours post-dose |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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 | Percentage of cumulative total radioactivity recovered relative to dose (Cum%Dose) in urine, feces, and urine+feces (0-168 hours) | Posted | Mean | Standard Deviation | Percent dose | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity AUClast in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq*h/mL | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity AUClast in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq*h/g | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity AUC[0-∞] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq*h/mL | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity AUC[0-∞] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq*h/g | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC extrapolated | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity AUC[Extrap(%)] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC extrapolated | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity Cmax in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq/mL | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity Cmax in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ngEq/g | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity Tmax in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: Tmax (time of Cmax) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity λz in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: λz (terminal phase rate constant) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Ae[t1-t2] (amount of total radioactivity excreted/recovered in urine, feces, and urine+feces within a given collection interval) | Posted | Geometric Mean | Geometric Coefficient of Variation | mgEq | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity T1/2 in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | Total radioactivity pharmacokinetic parameter: T1/2 (apparent terminal half-life) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity CumAe in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | CumAe (cumulative amount of total radioactivity excreted/recovered in urine, feces, and urine+feces) (0-168 hour) | Posted | Geometric Mean | Geometric Coefficient of Variation | mgEq | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Total Radioactivity CLr in Urine Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants | CLr (renal clearance) | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hour | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Unlabeled IDV184001 and M12 AUC[Last] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose to 168 hours post-dose |
|
|
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| Primary | Unlabeled IDV184001 and M12 AUC[0-∞] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Unlabeled IDV184001 and M12 AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC extrapolated | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Unlabeled IDV184001 and M12 Cmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Cmax (maximum observed concentration) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose to 168 hours post-dose |
|
|
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| Primary | Unlabeled IDV184001 and M12 Tmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Tmax (time of Cmax) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Unlabeled IDV184001 and M12 λz in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | λz (terminal phase rate constant) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | Pre-dose to 168 hours post-dose |
|
|
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| Primary | Unlabeled IDV184001 and M12 T1/2 in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | T1/2 (apparent terminal half-life) as data permit. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Pre-dose to 168 hours post-dose |
|
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| Primary | 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 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio in plasma | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | 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 | Ratio of unlabeled IDV184001 and M12 in plasma to plasma total radioactivity for Cmax (maximum observed concentration), where appropriate | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio in plasma | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Determination of percentage of AUC (area under the concentration-time curve) of each identified metabolites to total AUC in plasma | Posted | Number | Percentage of AUC | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Determination of percentage of dose of each identified metabolites in urine | Posted | Mean | Full Range | Percentage of dose | Pre-dose to 168 hours post-dose |
|
|
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| Primary | Percentage of Total AUC of Each Identified Metabolite in Feces Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants | Determination of percentage of AUC (area under the concentration-time curve) of M436 metabolite to total AUC in feces | Posted | Mean | Full Range | Percentage of AUC | Pre-dose to 168 hours post-dose |
|
|
|
| Primary | 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 | 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 | Posted | Mean | Standard Deviation | ml/g | Pre-dose to 168 hours post-dose |
|
|
|
| Secondary | 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 | Incidence, seriousness, severity, and relatedness of treatment-emergent adverse events. | 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. | Posted | Count of Participants | Participants | From informed consent signature to end of study (up to 11 days) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| PHOTOPHOBIA | Eye disorders | Systematic Assessment |
|
Not provided
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| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Urine, 12-24 hour post dose |
|
| Urine, 24-48 hour post dose |
|
| Urine, 48-72 hour post dose |
|
| Urine, 72-96 hour post dose |
|
| Urine, 96-120 hour post dose |
|
| Urine, 120-144 hour post dose |
|
| Urine, 144-168 hour post dose |
|
| Feces, 0-24 hour post dose |
|
| Feces, 24-48 hour post dose |
|
| Feces, 48-72 hour post dose |
|
| Feces, 72-96 hour post dose |
|
| Feces, 96-120 hour post dose |
|
| Feces, 120-144 hour post dose |
|
| Feces, 144-168 hour post dose |
|
| Urine+feces, 0-4 hour post dose |
|
| Urine+feces, 4-8 hour post dose |
|
| Urine+feces, 8-12 hour post dose |
|
| Urine+feces, 12-24 hour post dose |
|
| Urine+feces, 24-48 hour post dose |
|
| Urine+feces, 48-72 hour post dose |
|
| Urine+feces, 72-96 hour post dose |
|
| Urine+feces, 96-120 hour post dose |
|
| Urine+feces, 120-144 hour post dose |
|
| Urine+feces, 144-168 hour post dose |
|
| Title |
|---|
| Measurements |
|---|
|
|
| M422 Isomer 1 |
|
| M422 Isomer 2 |
|
| M275 Isomer 2 |
|
| M438 |
|
| M436 |
|
|
| M291, M275, and M289 Isomer 1 |
|
| M422 Isomer 1 and M628 Isomer 2 |
|
| Title | Measurements |
|---|---|
|
| 3 hours post dose |
|
| 4 hours post dose |
|
| 6 hours post dose |
|
| 8 hours post dose |
|
| 12 hours post dose |
|
| 24 hours post dose |
|
| 48 hours post dose |
|
| 72 hours post dose |
|
| 96 hours post dose |
|
| 120 hours post dose |
|
| 144 hours post dose |
|
| 168 hours post dose |
|
| Title | Measurements |
|---|---|
|
| Serious and study drug-related |
|
| Severe |
|
| Toxicity Grade >= 3 |
|
| Resulted in study discontinuation |
|
| Resulted in death |
|