A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
- Registration Number
- NCT05048784
- Lead Sponsor
- Amgen
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Sequence ABC Sotorasib Participants will be administered sotorasib dose A orally in the following order: * Treatment A - as 3 tablets (test 1) * Treatment B - as 8 tablets (reference) * Treatment C - as 3 tablets (test 2) Treatment Sequence BAC Sotorasib Participants will be administered sotorasib dose A orally in the following order: * Treatment B - as 8 tablets (reference) * Treatment A - as 3 tablets (test 1) * Treatment C - as 3 tablets (test 2)
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B 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) 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.
Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B 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) 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.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B 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) 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.
- Secondary Outcome Measures
Name Time Method Food Effect: AUCinf 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) Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.
Food Effect: Cmax 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) Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.
Number of Participants Who Experienced a Treatment-emergent AE (TEAE) Day 1 to Day 9 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.Food Effect: AUClast 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) Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Dallas, Texas, United States