A Study to Understand the Effect of a Study Medicine Called ARV-471 on Rosuvastatin in Healthy Adults

NCT05652660 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C4891029
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand if ARV-471 affects how a BCRP substrate (rosuvastatin) gets into the body in healthy adults. All participants in this study will receive one dose of rosuvastatin alone by mouth in Period 1. In Period 2, everyone will receive one dose of ARV-471 by mouth 90 min before one dose of rosuvastatin by mouth. The levels of rosuvastatin in Period 1 will be compared to the levels of rosuvastatin in Period 2 to determine if ARV-471 affects how rosuvastatin gets into the body differently in healthy adults. All participants will stay at the study clinic for 10 days and 9 nights.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of Rosuvastatin

  Cmax was defined as maximum plasma concentration. Cmax of rosuvastatin was observed directly from data.

  0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2

• Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rosuvastatin

  AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast of rosuvastatin was determined using Linear/Log trapezoidal method.

  0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2

Secondary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)

• Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)

  Baseline (Period 1 Day -1) up to Period 2 Day 4 (10 days)

• Number of Participants With Electrocardiogram (ECG) Abnormalities

  Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days)

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

  Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days)

Study Arms (1)

Rosuvastatin with/without ARV-471

EXPERIMENTAL

Rosuvastatin administered as a single dose in Period 1 and Period 2. ARV-471 administered as a single dose in Period 2.

Drug: ARV-471; Drug: Rosuvastatin

Interventions

ARV-471 DRUG

Experimental

Also known as: PF-07850327

Rosuvastatin with/without ARV-471

Rosuvastatin DRUG

Probe substrate

Also known as: CRESTOR®

Rosuvastatin with/without ARV-471

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or female participants of non-childbearing potential must be 18 to 65 years of age, inclusive at the time of signing informed consent document.
• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical exam, laboratory tests, vital sign and standard 12-lead ECGs.
• BMI of 17.5 to 32 kg/m2; and a total body weight ≥45 kg.

You may not qualify if:

• 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).
• Pregnant female participants; breastfeeding female participants; Male participants with partners currently pregnant; fertile male participants who have partners of childbearing potential and are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
• Participants with known history of hypersensitivity to statin medication, sensitivity to ARV-471 or rosuvastatin or any of the formulation components of ARV-471 or rosuvastatin.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• 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.
• History of use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.

Sponsors & Collaborators

• Pfizer: lead
• Arvinas Estrogen Receptor, Inc.: collaborator

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: December 9, 2022
• Primary Completion: February 9, 2023
• Study Completion: March 6, 2023
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)