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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

Summary

This trial tests how the body handles ARV-471, a liquid medicine taken by mouth, in healthy adults who cannot have children.

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
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

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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
4,595 Previous Clinical Trials
12,868,758 Total Patients Enrolled
Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
2,358 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,367 Total Patients Enrolled
~6 spots leftby Sep 2025
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