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[oxoisoindolin-14C]ARV-471 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose

Awards & highlights

Study Summary

This trial tests how a medicine is processed in the body of healthy, non-reproductive individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-dose, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent Oral Clearance (CL/F) of ARV-471

Apparent Oral Clearance (CL/F) of Total Radioactivity

Apparent Volume of Distribution (Vz/F) of ARV-471

+15 more

Secondary outcome measures

Number of Participants With Abnormalities in Physical Examinations

Number of Participants With Clinical Laboratory Abnormalities

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: [phenyl-14C]ARV-471Experimental Treatment1 Intervention

[phenyl-14C]ARV-471 is administered as a single dose

Group II: [oxoisoindolin-14C]ARV-471Experimental Treatment1 Intervention

[oxoisoindolin-14C]ARV-471 is administered as a single dose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[phenyl-14C]ARV-471

2023

Completed Phase 1

~20

[oxoisoindolin-14C]ARV-471

2023

Completed Phase 1

~20

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,567 Previous Clinical Trials

10,911,862 Total Patients Enrolled

Arvinas Estrogen Receptor, Inc.Industry Sponsor

17 Previous Clinical Trials

2,357 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,474 Previous Clinical Trials

8,093,030 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current recruitment number for this research endeavor?

"Affirmative. According to information published on clinicaltrials.gov, this trial is still searching for suitable candidates and was last updated on June 29th 2023. 12 participants are needed from a single medical centre."

Answered by AI

Is there still space in the experiment for participants?

"As indicated on the clinicaltrials.gov website, this ongoing trial commenced recruitment in June 12th 2023 and was last refreshed on June 29th of the same year."

Answered by AI

Has the FDA granted approval to [phenyl-14C]ARV-471?

"Our risk assessment for [phenyl-14C]ARV-471 is rated a 1 due to its Phase 1 status, signifying there is only preliminary data available regarding safety and effectiveness."

Answered by AI

What are the primary aims of this medical research endeavor?

"This clinical trial has two main objectives: to measure the Maximum Observed Plasma Concentration (Cmax) of ARV-471 and its epimer, ARV-473; as well as record secondary outcomes such as Number of Participants With Clinical Laboratory Abnormalities, Electrocardiogram Abnormalities, and Clinically Significant Change From Baseline in Vital Signs. These measurements will be taken at multiple points from Day 1 pre-dose up until 264 hours post dose."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Understand How the Study Medicine Called ARV-471 is Processed in Healthy Adults

2023. "A Study to Understand How the Study Medicine Called ARV-471 is Processed in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05930925.