Opioid Use DisorderPhase 1NCT05974046
Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants
A Phase 1 study testing [14C]IDV184001AN in people with Opioid Use Disorder, run by Indivior Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- [14C]IDV184001AN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2023to 21 Jul 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant must be 19 to 55 years of age inclusive, at the time of signing the informed consent.
- Participant must have body weight of a minimum of 50.0 kg at the Screening Visit and body mass index within the range 18.0 to 32.0 kg/m2 (inclusive).
- Participant must be male and who is healthy as determined by medical evaluation.
- Participant agrees to follow contraception guidelines from the time of dosing of study drug until at least 90 days after dosing of study drug. This includes use of highly effective contraception if sexually active with a non-pregnant partner of child-bearing potential, and agreement not to donate sperm from dosing until at least 90 days post-dose. There are no restrictions for a vasectomised male provided his vasectomy has been performed 4 months or more prior to dosing.
- Participant must be continuous non smoker who has not used nicotine and tobacco containing products for at least 3 months prior to dosing based on participant self-reporting.
- Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and compliance with contraception guidelines.
Who cannot join
- 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.
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- 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:
- Uncontrolled arrhythmias
- History of congestive heart failure
- QTcF >450 msec or history of prolonged QT syndrome
- Myocardial infarction
- Uncontrolled symptomatic angina
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Dose of Oral [14C]-IDV184001AN in Healthy Adult Male Participants
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.
Read the detailed description
The study is designed as an open label, single-dose study in healthy adult participants for the following reasons:
- Oral administration of IDV184001AN has demonstrated linear PK and thus [14C]IDV184001AN will be given as a single dose.
- A comparator is not necessary for the evaluation of the objectives.
- Blinding of the study treatment is not required as there is no comparator.
- Conducting the study in healthy participants mitigates the potential confounding effects of the disease state and concomitant medications.
- Conditions
- Opioid Use Disorder
- Being tested
- [14C]IDV184001AN
- Keywords
- healthy volunteers, ADME, OUD, radiolabel, metabolism
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]IDV184001ANDrug
Also called [14C]-IDV184001
[14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | [14C]IDV184001AN Receives: Drug: [14C]IDV184001AN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose to 168 hours post-dose
Secondary outcomes (1)
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.
Measured: From informed consent signature to end of study (up to 11 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start10 Jul 2023
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Director Clinical Development, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974046
- Sponsor's protocol ID
- INDV-2000-105
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2023
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Dose of Oral [14C]-IDV184001AN in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT05974046
- Acronym / sponsor ID
- INDV-2000-105
- Conditions
- Opioid Use Disorder
- Keywords
- healthy volunteers, ADME, OUD, radiolabel, metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed as an open label, single-dose study in healthy adult participants for the following reasons:
- Oral administration of IDV184001AN has demonstrated linear PK and thus [14C]IDV184001AN will be given as a single dose.
- A comparator is not necessary for the evaluation of the objectives.
- Blinding of the study treatment is not required as there is no comparator.
- Conducting the study in healthy participants mitigates the potential confounding effects of the disease state and concomitant medications.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: [14C]IDV184001AN[14C]IDV184001AN |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
Key exclusion criteria (32 listed)
- Participants are excluded from the study if any of the following criteria apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]IDV184001ANAlso: [14C]-IDV184001[14C]-IDV184001AN 200 mg/~100 µCi/ 15 g oral suspension | Drug | Treatment |
Primary outcome
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
Time frame: Pre-dose to 168 hours post-dose
Percentage of total radioactivity recovered relative to dose (%Dose) in urine, feces and urine + feces (by time interval)
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
Time frame: Pre-dose to 168 hours post-dose
Percentage of cumulative total radioactivity recovered relative to dose (Cum%Dose) in urine, feces, and urine+feces (0-168 hours)
Total Radioactivity AUClast in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
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 AUClast in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
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 AUC[0-∞] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Total radioactivity pharmacokinetic parameter: AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Total Radioactivity AUC[0-∞] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Total radioactivity pharmacokinetic parameter: AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Total Radioactivity AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Total radioactivity pharmacokinetic parameter: AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Total Radioactivity AUC[Extrap(%)] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Total radioactivity pharmacokinetic parameter: AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Total Radioactivity Cmax in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: 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/mL") reflect the peak concentration that occurred from 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
Time frame: 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 Tmax in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Total radioactivity pharmacokinetic parameter: Tmax (time of Cmax) as data permit.
Total Radioactivity λz in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Total radioactivity pharmacokinetic parameter: λz (terminal phase rate constant) as data permit.
Total Radioactivity Ae[t1-t2] in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Ae[t1-t2] (amount of total radioactivity excreted/recovered in urine, feces, and urine+feces within a given collection interval)
Total Radioactivity T1/2 in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Total radioactivity pharmacokinetic parameter: T1/2 (apparent terminal half-life) as data permit.
Total Radioactivity CumAe in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
CumAe (cumulative amount of total radioactivity excreted/recovered in urine, feces, and urine+feces) (0-168 hour)
Total Radioactivity CLr in Urine Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
CLr (renal clearance)
Unlabeled IDV184001 and M12 AUC[Last] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
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.
Unlabeled IDV184001 and M12 AUC[0-∞] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
AUC[0-∞] (area under the concentration-time curve from time 0 extrapolated to infinite time) as data permit.
Unlabeled IDV184001 and M12 AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
AUC[extrap(%)] (percent of the area under the concentration-time curve due to extrapolation) as data permit.
Unlabeled IDV184001 and M12 Cmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Cmax (maximum observed concentration) as data permit.
Unlabeled IDV184001 and M12 Tmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Tmax (time of Cmax) as data permit.
Unlabeled IDV184001 and M12 λz in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
λz (terminal phase rate constant) as data permit.
Unlabeled IDV184001 and M12 T1/2 in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
T1/2 (apparent terminal half-life) as data permit.
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
Time frame: Pre-dose to 168 hours post-dose
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 Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Ratio of unlabeled IDV184001 and M12 in plasma to plasma total radioactivity for Cmax (maximum observed concentration), where appropriate
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Determination of percentage of AUC (area under the concentration-time curve) of each identified metabolites to total AUC in plasma
Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Determination of percentage of dose of each identified metabolites in urine
Percentage of Total AUC of Each Identified Metabolite in Feces Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
Time frame: Pre-dose to 168 hours post-dose
Determination of percentage of AUC (area under the concentration-time curve) of M436 metabolite to total AUC in feces
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
Time frame: Pre-dose to 168 hours post-dose
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
1 secondary outcome
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
Time frame: From informed consent signature to end of study (up to 11 days)
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Director Clinical Development study director
Indivior Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]IDV184001AN in people with Opioid Use Disorder, run by Indivior Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Pre-dose to 168 hours post-dose). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.