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Phase 1 N=7 Basic Science

Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants

Opioid Use Disorder

Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: 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 — 19.0; 25.3; 13.1; 13.5 Percentage of dose

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
[14C]IDV184001AN (Drug)
Age
Adult · 19+ yrs
Sex
Male
Sponsor
Indivior Inc.
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
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
19.0; 25.3; 13.1; 13.5; 5.04; 0.941
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
79.7; 21.1; 101
PRIMARY
Total Radioactivity AUClast in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
77300
PRIMARY
Total Radioactivity AUClast in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
37700
PRIMARY
Total Radioactivity AUC[0-∞] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
83000
PRIMARY
Total Radioactivity AUC[0-∞] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
40100
PRIMARY
Total Radioactivity AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
6.84
PRIMARY
Total Radioactivity AUC[Extrap(%)] in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
5.60
PRIMARY
Total Radioactivity Cmax in Plasma Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
6800
PRIMARY
Total Radioactivity Cmax in Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
3980
PRIMARY
Total Radioactivity Tmax in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
2.01; 1.94
PRIMARY
Total Radioactivity λz in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
0.0180; 0.0775
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
38.8; 51.7; 26.8; 27.6; 10.3; 1.92
PRIMARY
Total Radioactivity T1/2 in Plasma and Whole Blood Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
38.5; 8.94
PRIMARY
Total Radioactivity CumAe in Urine, Feces, and Urine+Feces Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
162; 41.9; 206
PRIMARY
Total Radioactivity CLr in Urine Following a Single Oral Dose of [14C]-IDV184001AN in Healthy Adult Male Participants
2.10
PRIMARY
Unlabeled IDV184001 and M12 AUC[Last] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
7150; 8940
PRIMARY
Unlabeled IDV184001 and M12 AUC[0-∞] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
7250; 9070
PRIMARY
Unlabeled IDV184001 and M12 AUC[Extrap(%)] in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
0.775; 1.08
PRIMARY
Unlabeled IDV184001 and M12 Cmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
1380; 1140
PRIMARY
Unlabeled IDV184001 and M12 Tmax in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
1.43; 2.29
PRIMARY
Unlabeled IDV184001 and M12 λz in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
0.277; 0.172
PRIMARY
Unlabeled IDV184001 and M12 T1/2 in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
2.50; 4.02
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
0.0926; 0.120
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
0.202; 0.173
PRIMARY
Percentage of Total AUC of Each Identified Metabolite in Plasma Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
23.6; 21.9; 15.5; 16.7; 13.7; 3.0
PRIMARY
Percentage of Dose of Each Identified Metabolite in Urine Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
21.9; 8.2; 6.7; 7.6; 9.5
PRIMARY
Percentage of Total AUC of Each Identified Metabolite in Feces Following a Single Oral Dose of [14C] IDV184001AN in Healthy Adult Male Participants
14.7
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
0.571; 0.567; 0.584; 0.574; 0.564; 0.574
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
1; 0; 1; 0; 0; 0

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

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 149 mmHg; Diastolic 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05974046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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