Trial Outcomes & Findings for A Study to Understand the Effect of a Study Medicine Called ARV-471 on Rosuvastatin in Healthy Adults (NCT NCT05652660)
NCT ID: NCT05652660
Last Updated: 2024-07-26
Results Overview
Cmax was defined as maximum plasma concentration. Cmax of rosuvastatin was observed directly from data.
COMPLETED
PHASE1
12 participants
0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2
2024-07-26
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Period 1 (5 Days)
STARTED
|
12
|
|
Period 1 (5 Days)
Treated
|
12
|
|
Period 1 (5 Days)
COMPLETED
|
12
|
|
Period 1 (5 Days)
NOT COMPLETED
|
0
|
|
Period 2 (4 Days)
STARTED
|
12
|
|
Period 2 (4 Days)
Treated
|
12
|
|
Period 2 (4 Days)
COMPLETED
|
12
|
|
Period 2 (4 Days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Understand the Effect of a Study Medicine Called ARV-471 on Rosuvastatin in Healthy Adults
Baseline characteristics by cohort
| Measure |
All Participants
n=12 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.
|
|---|---|
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Age, Continuous
|
50.5 Years
STANDARD_DEVIATION 9.16 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2Population: All participants enrolled and who took at least 1 dose of study intervention and had at least 1 PK parameter of interest.
Cmax was defined as maximum plasma concentration. Cmax of rosuvastatin was observed directly from data.
Outcome measures
| Measure |
Period 1: Rosuvastatin
n=12 Participants
In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg.
|
Period 2: ARV-471 + Rosuvastatin
n=12 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.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Rosuvastatin
|
2.178 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53
|
2.625 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours post dose on Day 1 in Periods 1 and 2Population: All participants enrolled and who took at least 1 dose of study intervention and had at least 1 PK parameter of interest.
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.
Outcome measures
| Measure |
Period 1: Rosuvastatin
n=12 Participants
In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg.
|
Period 2: ARV-471 + Rosuvastatin
n=12 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.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rosuvastatin
|
31.40 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
34.71 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
SECONDARY outcome
Timeframe: From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)Population: All participants enrolled and who took at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Period 1: Rosuvastatin
n=12 Participants
In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg.
|
Period 2: ARV-471 + Rosuvastatin
n=12 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.
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|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-emergent AEs
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-emergent SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Period 1 Day -1) up to Period 2 Day 4 (10 days)Population: All participants enrolled and who took at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Period 1: Rosuvastatin
n=12 Participants
In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg.
|
Period 2: ARV-471 + Rosuvastatin
n=12 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.
|
|---|---|---|
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Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days)Population: All participants enrolled and who took at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Period 1: Rosuvastatin
n=12 Participants
In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg.
|
Period 2: ARV-471 + Rosuvastatin
n=12 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.
|
|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Period 1 Day 1) up to Period 2 Day 4 (9 days)Population: All participants enrolled and who took at least 1 dose of study intervention.
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.
Outcome measures
| Measure |
Period 1: Rosuvastatin
n=12 Participants
In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg.
|
Period 2: ARV-471 + Rosuvastatin
n=12 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.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
|
0 Participants
|
0 Participants
|
Adverse Events
Period 1: Rosuvastatin
Period 2: ARV-471 + Rosuvastatin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1: Rosuvastatin
n=12 participants at risk
In Period 1 Day 1, participants received a single oral dose of rosuvastatin 10 mg.
|
Period 2: ARV-471 + Rosuvastatin
n=12 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
0.00%
0/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
8.3%
1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
8.3%
1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
8.3%
1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 6) of study intervention (up to 41 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place