A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

NCT05327491
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Phase
Phase 1
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Recruitment status
Completed
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Participants
146
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Lead sponsor
Amgen
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Start date
2022-03-21
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Number of sites
4
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Summary
The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.
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Short title
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
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Official title
An Open-label, Randomized, Crossover Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
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Control arm
Open label
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2022-07-17
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First posted
2022-04-14
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Registry last updated
2023-12-14
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Primary completion date
2022-07-17
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Start date
2022-03-21
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Actual participants
146
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Participants
146
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05327491
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ClinicalTrials.gov ID
NCT05327491
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Registry record
Open registry record
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Allocation
Randomised
Model
Crossover
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib

    Timeframe: Predose, 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 the 1st day of each period (Days 1 and 4)

  2. Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib

    Timeframe: Predose, 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 the 1st day of each period (Days 1 and 4)

  3. Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib

    Timeframe: Predose, 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 on the 1st day of each period (Days 1 and 4)

  1. Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

    Timeframe: Day 1 to Day 9

    A TEAE was defined as an adverse event (AE) that started during or after dosing, or started prior to dosing and increased in severity after dosing within each period. Clinically significant laboratory tests, 12-lead electrocardiogram (ECG), or vital sign results as assessed by the Investigator were also recorded as adverse events.

  2. Period 3: Cmax of Sotorasib

    Timeframe: Predose, 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 the 1st day of Period 3 (Day 7)

  3. Period 3: AUClast of Sotorasib

    Timeframe: Predose, 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 on the 1st day of Period 3 (Day 7)

  4. Period 3: AUCinf of Sotorasib

    Timeframe: Predose, 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 the 1st day of Period 3 (Day 7)

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
Yes

  • 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 participants safety or interfere with the study evaluation, procedures, or completion.
Sources for eligibility
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  • Labcorp Clinical Research Unit - Daytona BeachDaytona Beach, United States
  • Miami Research Associates LLC - Main Campus / Late PhaseSouth Miami, United States
  • Labcorp Clinical Research Unit - DallasDallas, United States
  • Labcorp Clinical Research Unit - MadisonMadison, United States
Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Targets (1)