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Study Complete
Sponsor ID
20210088

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

Sponsor ID
20210088
Clinicaltrials.gov ID
NCT05327491
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
146
Additional Study Details

Protocol Summary

Primary Outcome Measures

Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib

Timeframe: Day 1 and Day 4 of of Overall Study

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

Timeframe: Day 1 and Day 4 of of Overall Study

Period 1 and 2: Area Under the Plasma Concentration‑time Curve from Time Zero to Infinity (AUCinf) of Sotorasib

Timeframe: Day 1 and Day 4 of Overall Study

Secondary Outcome Measures

Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)

Timeframe: Day 1 to Day 9

Period 3: Cmax of Sotorasib

Timeframe: Day 7 to Day 9

Period 3: AUClast of Sotorasib

Timeframe: Day 7 to Day 9

Period 3: AUCinf of Sotorasib

Timeframe: Day 7 to Day 9

Locations

Location
Status
Contact Us
Location
Labcorp Clinical Research Unit - Dallas
Dallas, TX, United States, 75247-4989
Status
Recruiting
Location
Labcorp Clinical Research Unit - Daytona Beach
Daytona Beach, FL, United States, 32117-5116
Status
Recruiting
Location
Labcorp Clinical Research Unit - Madison
Madison, WI, United States, 53704-2526
Status
Recruiting
Location
Miami Research Associates LLC - Main Campus / Late Phase
South Miami, FL, United States, 33143-5026
Status
Recruiting
Study Info
Age
N/A
Condition
  • Healthy Subjects
    • Sex
    N/A
    Trial Dates
    Apr 2022 - Jul 2022
    Inclusion and Exclusion 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 participants safety or interfere with the study evaluation, procedures, or completion.