CompletedPhase 1

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

United States7 participantsStarted 2023-07-10

Plain-language 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.

Who can participate

Age range19 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

✕. 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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Pre-dose to 168 hours post-dose

Trial details

NCT IDNCT05974046

SponsorIndivior Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-21

Results submitted2024-07-19

View on ClinicalTrials.gov More Opioid Use Disorder trials

Who can participate

Age range19 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

✕. 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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Pre-dose to 168 hours post-dose