A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Healthy Participants Clinical Trial

Official title:

An Open-label, Randomized, Two-way Crossover, Bioequivalence Study in Healthy Volunteers to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05048784
• Other study ID #: 20210093
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2021
• Est. completion date: February 18, 2022

Study information

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

Clinical Trial Summary

The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.

• Body mass index, between 18 and 30 kg/m^2 (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 participant safety or interfere with the study evaluation, procedures, or completion.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Sotorasib
Oral tablet

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Dallas	Texas
United States	Covance Clinical Research Unit	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 Sotorasib for Treatments A and B	Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma pharmacokinetic (PK) parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified.	Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2)
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B	Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma PK parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified.	Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2)
Primary	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B	Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma PK parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified.	Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2)
Secondary	Number of Participants Who Experienced a Treatment-emergent AE (TEAE)	An AE is any untoward medical occurrence in a participant irrespective of a causal relationship with the study treatment.; Any abnormal clinical laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., 12-lead electrocardiogram or vital signs measurements), including those that worsen from baseline, that are considered clinically significant in the medical and scientific judgment of the Investigator (i.e., not related to progression of underlying disease) were considered AEs.	Day 1 to Day 9
Secondary	Food Effect: Cmax of Sotorasib	Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.	Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3)
Secondary	Food Effect: AUClast of Sotorasib	Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.	Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3)
Secondary	Food Effect: AUCinf of Sotorasib	Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.	Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3)

External Links

•   AmgenTrials clinical trials website