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BCRP Inhibitor

Rosuvastatin with/without 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 period 2 - day 1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose
Awards & highlights

Study Summary

This trial explores how a medication (ARV-471) affects how another medication (rosuvastatin) is absorbed in healthy adults. Participants stay at the clinic for 10 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period 2 - day 1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and period 2 - day 1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 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
Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] of rosuvastatin when rosuvastatin is administered alone
Area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] of rosuvastatin when rosuvastatin is administered with ARV-471
Maximum observed plasma concentration (Cmax) of rosuvastatin when rosuvastatin is administered alone
+1 more
Secondary outcome measures
Number of participants with clinical laboratory abnormalities
Number of participants with clinically significant change from baseline in vital signs
Number of participants with electrocardiogram (ECG) abnormalities
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rosuvastatin with/without ARV-471Experimental Treatment2 Interventions
Rosuvastatin administered as a single dose in Period 1 and Period 2. ARV-471 administered as a single dose in Period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARV-471
2022
Completed Phase 1
~50
Rosuvastatin
2019
Completed Phase 4
~3150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,671 Total Patients Enrolled
Arvinas Estrogen Receptor, Inc.Industry Sponsor
16 Previous Clinical Trials
2,309 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,089,108 Total Patients Enrolled

Frequently Asked Questions

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

Does this research involve participants of any age, including those over forty?

"This research requires participants to be legally of age (18+) and no older than 65."

Answered by AI

Has the combination of Rosuvastatin and ARV-471 been given formal authorization by the FDA?

"Our internal safety assessment calculated a score of 1 for the combination of Rosuvastatin and ARV-471. This is based on this being an early phase trial, meaning there are limited clinical data that support its efficacy or safety profile."

Answered by AI

What is the current enrollment criterion for this clinical experiment?

"Absolutely. Clinicaltrials.gov displays that this research is currently enrolling patients, with the trial first posted on December 9th 2022 and last edited on December 29th 2022. At present, 12 individuals are needed to partake in the study at 1 location."

Answered by AI

Are volunteers still being welcomed for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical experiment is still recruiting participants as of December 29th 2022; it was first advertised on the 9th of December that same year. Just 12 people need to be enrolled between a single location."

Answered by AI

Who is eligible to partake in the research study?

"This medical experiment is recruiting 12 healthy adults aged 18 to 65 with a Body Mass Index (BMI) between 17.5 and 32 kg/m2, as well as total body weight of at least 45kg., Male or female candidates must pass a comprehensive physical examination alongside laboratory tests, vital signs testing, ECGs etc. Furthermore, all participants are needed to have the capacity for informed consent prior to joining the trial."

Answered by AI

What is the purpose of this research endeavor?

"The aim of this trial is to determine the maximal plasma concentration (Cmax) of rosuvastatin when administered alone. This will be assessed via 1-day predose and postdose measurements at hours 1, 2, 3, 4, 6, 8 12 24 36 48 72. Secondary objectives include assessing adverse events/serious adverse events in patients as well as determining any clinically significant changes from baseline vital signs such as blood pressure or pulse rate after a 5 minute rest period while lying down."

Answered by AI
~5 spots leftby Mar 2025