Clinical trial NCT05048784: A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
Official title: An Open-label, Randomized, Two-way Crossover, Bioequivalence Study in Healthy Volunteers to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Sotorasib
AMG 510
Bioequivalence
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B
timeFrame: 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)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B
timeFrame: 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)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B
timeFrame: 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 outcomes:
measure: Number of Participants Who Experienced a Treatment-emergent AE (TEAE)
timeFrame: Day 1 to Day 9
measure: Food Effect: Cmax of Sotorasib
timeFrame: 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)
measure: Food Effect: AUClast of Sotorasib
timeFrame: 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)
measure: Food Effect: AUCinf of Sotorasib
timeFrame: 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)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit
state: Florida
city: Dallas
country: United States
facility: Covance Clinical Research Unit
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: