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Study Complete
Sponsor ID
20200426

Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Sponsor ID
20200426
Clinicaltrials.gov ID
NCT05045638
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.

Additional Study Details

Phase
Phase 1
Product
AMG 510
Type
Interventional
Masking
None (Open Label)
Enrollment
13
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin

Timeframe: Day 1 to Day 11

Area Under the Plasma Concentration‑Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin

Timeframe: Day 1 to Day 11

AUC from Time Zero to Infinity (AUCinf) of Rosuvastatin

Timeframe: Day 1 to Day 11

Secondary Outcome Measures

Number of Participants Reporting any Adverse Events

Timeframe: 36 days

Number of Participants with Clinically Significant Abnormal Changes from Baseline in Clinical Laboratory Tests

Timeframe: Baseline (Day 1) to Day 11

Number of Participants with Clinically Significant Abnormal Changes from Baseline in 12-Leads Electrocardiogram (ECG) Findings

Timeframe: Baseline (screening) to Day 1

Number of Participants with Clinically Significant Abnormal Changes from Baseline in Vital Signs

Timeframe: Baseline (Day 1) to Day 11

Cmax of Sotorasib

Timeframe: Day 6 to Day 8

AUClast of Sotorasib

Timeframe: Day 6 to Day 8

AUCinf of Sotorasib

Timeframe: Day 6 to Day 8

Locations

Location
Status
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Location
Covance Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States, 32117-5116
Status
Recruiting
Study Info
Age
18 - 60
Condition
  • Healthy Subjects
    • Sex
    All
    Trial Dates
    Sep 2021 - Oct 2021
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening. - Body mass index, between 18 and 30 kg/m2 (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 subject safety or interfere with the study evaluation, procedures, or completion.