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

Completed · Phase 1

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT05974046

Run by

Indivior Inc.

People needed

7

Starts

2023-07-10

Expected to finish

2023-07-21

Last updated by the study team

2025-02-13

Who can join

Age: 19 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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.

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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