Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Arvinas Estrogen Receptor, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARV-471 | Drug | Experimental |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
The study consisted of 2 Periods in a single fixed sequence. A total of 12 participants were enrolled in the study and received study intervention.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received a single oral dose of rosuvastatin 10 milligram (mg) on Period 1 Day 1. A minimum washout period of 5 days was required after rosuvastatin administration in Period 1. After completion of Period 1, participants received a single oral dose of ARV-471 (PF-07850327) 200 mg followed by a single oral dose of rosuvastatin 10 mg on Period 2 Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (5 Days) |
| ||||||||||||||||
| Period 2 (4 Days) |
|
The baseline analysis population defined as all participants enrolled and who took at least 1 dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received a single oral dose of rosuvastatin 10 milligram (mg) on Period 1 Day 1. A minimum washout period of 5 days was required after rosuvastatin administration in Period 1. After completion of Period 1, participants received a single oral dose of ARV-471 (PF-07850327) 200 mg followed by a single oral dose of rosuvastatin 10 mg on Period 2 Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of Rosuvastatin | Cmax was defined as maximum plasma concentration. Cmax of rosuvastatin was observed directly from data. | All participants enrolled and who took at least 1 dose of study intervention and had at least 1 PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2 |
|
From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Rosuvastatin | In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2022 | Feb 9, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2023 | Feb 9, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rosuvastatin | Drug | Probe substrate |
|
|
| 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) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid, cystatinC); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (dipstick [decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, bilirubin], microscopy. Abnormality was determined at the investigator's discretion. | Baseline (Period 1 Day -1) up to Period 2 Day 4 (10 days) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria include a) a postdose QTc corrected using Fridericia's formula (QTcF) increased by >60 millisecond (ms) from the baseline and the absolute QTcF value >450 ms; or b) an absolute QTcF value >500 ms for any scheduled ECG. | 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 | Vital signs (blood pressure and pulse rate) were obtained with participant following at least a 5-minute rest in a supine position. Clinical significance of vital signs was determined at the investigator's discretion. | Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days) |
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
In Period 2, participants received a single oral dose of ARV-471 (PF-07850327) 200 mg on Day 1 followed by a single oral dose of rosuvastatin 10 mg.
|
|
|
| Primary | 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. | All participants enrolled and who took at least 1 dose of study intervention and had at least 1 PK parameter of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days) |
|
|
|
| Secondary | Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid, cystatinC); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (dipstick [decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, bilirubin], microscopy. Abnormality was determined at the investigator's discretion. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (Period 1 Day -1) up to Period 2 Day 4 (10 days) |
|
|
|
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria include a) a postdose QTc corrected using Fridericia's formula (QTcF) increased by >60 millisecond (ms) from the baseline and the absolute QTcF value >450 ms; or b) an absolute QTcF value >500 ms for any scheduled ECG. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Vital signs (blood pressure and pulse rate) were obtained with participant following at least a 5-minute rest in a supine position. Clinical significance of vital signs was determined at the investigator's discretion. | All participants enrolled and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Period 2: ARV-471 + Rosuvastatin | In Period 2, participants received a single oral dose of ARV-471 (PF-07850327) 200 mg on Day 1 followed by a single oral dose of rosuvastatin 10 mg. | 0 | 12 | 0 | 12 | 3 | 12 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Mixed Model |