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

NCT05974046 | Completed Phase 1 Results FDA Drug

• 1 other identifier: INDV-2000-105
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder

Keywords

healthy volunteers; ADME; OUD; radiolabel; metabolism

Outcome Measures

Primary Outcomes (29)

• 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.

  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

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

  From informed consent signature to end of study (up to 11 days)

Study Arms (1)

Treatment

EXPERIMENTAL

\[14C\]IDV184001AN

Drug: [14C]IDV184001AN

Interventions

[14C]IDV184001AN DRUG

\[14C\]-IDV184001AN 200 mg/\~100 µCi/ 15 g oral suspension

Also known as: [14C]-IDV184001

Treatment

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Global Director
• Organization: Clinical Development

trialdisclosure@indivior.com

(804) 594-4488

Study Officials

• Global Director Clinical Development

  Indivior Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: August 3, 2023
• Study Start: July 10, 2023
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)