Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Healthy Participants Clinical Trial

Official title:

A Phase I, Open-label, Fixed Sequence Crossover Study to Investigate the Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin, a Breast Cancer Resistance Protein Substrate, in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045638
• Other study ID #: 20200426
• Status: Completed
• Phase: Phase 1
• Start date: August 20, 2021
• Est. completion date: October 10, 2021

Study information

• Verified date: October 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 10, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
• Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
• Females of nonchildbearing potential

Exclusion criteria:

• Inability to swallow oral medication or history of malabsorption syndrome.
• History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
• Poor peripheral venous access.
• History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Rosuvastatin
Oral dose
• Sotorasib
Oral dose

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit - Daytona Beach	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin	The pharmacokinetic (PK) parameters were determined using standard non-compartmental methods.	Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6
Primary	Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin	The PK parameters were determined using standard non-compartmental methods.	Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6
Primary	AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin	The PK parameters were determined using standard non-compartmental methods.	Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6
Secondary	Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs)	Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms (ECGs), and vital signs results were recorded as AEs.	Day 1 to Day 41
Secondary	Cmax of Sotorasib	The PK parameters were determined using standard non-compartmental methods.	Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6
Secondary	AUClast of Sotorasib	The PK parameters were determined using standard non-compartmental methods.	Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6
Secondary	AUCinf of Sotorasib	The PK parameters were determined using standard non-compartmental methods.	Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6

External Links

•   AmgenTrials clinical trials website