Healthy volunteers help scientists track how ARV-471 moves through the body
NCT ID NCT05930925
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how healthy adults absorb, break down, and eliminate the experimental drug ARV-471. Twelve participants each took a single radioactive dose of the drug. Researchers measured levels in blood, urine, and stool to understand the drug's path through the body. This was not a treatment study and offered no direct health benefit to participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ARV-471 (a radioactive form of the drug)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Aug 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. * Male and female participants of non-childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG monitoring. * Total body weight \>50 kg (110 lb). * An informed consent document signed and dated by the subject. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * History of clinically significant thromboembolic or cerebrovascular events. * History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed. * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Use of prescription or nonprescription medications, including vitamins, dietary and herbal supplements are prohibited in this study. A washout of 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention is required, or a longer washout is required for those that fall into the categories below: * Moderate/strong CYP3A inducers; these are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention. * Moderate/strong CYP3A inhibitors; these are prohibited within 14 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. * Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). * A positive urine drug test. * Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. * Renal impairment as defined by an eGFR in adults of \<60 mL/min. * Hematuria as defined as \>1+ heme on urine dipstick. * Proteinuria or Albuminuria as defined as \>1+ protein on urine dipstick OR positive dipstick for albumin OR Albumin/Cr ratio on spot urine (UA) \>30 mg/g. * Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF \>450 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias). * Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary: * AST or ALT level \>1.0× ULN; * Total bilirubin level \>1.0 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN. * History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine). * Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing. * History of sensitivity to heparin or heparin induced thrombocytopenia. * Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol. * Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. * History of sensitivity to ARV-471 or any of the formulation components of ARV 471. * Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, or IBS). * Participants enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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PPD Phase I Clinic
Austin, Texas, 78744, United States
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