Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Rosuvastatin alone
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Drug: Rosuvastatin
Oral dose
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Experimental: Rosuvastatin + sotorasib
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Drug: Rosuvastatin
Oral dose
Drug: Sotorasib
Oral dose
Other Names:
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Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin [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 [Day 1 to Day 11]
- AUC from Time Zero to Infinity (AUCinf) of Rosuvastatin [Day 1 to Day 11]
Secondary Outcome Measures
- Number of Participants Reporting any Adverse Events [36 days]
- Number of Participants with Clinically Significant Abnormal Changes from Baseline in Clinical Laboratory Tests [Baseline (Day 1) to Day 11]
- Number of Participants with Clinically Significant Abnormal Changes from Baseline in 12-Leads Electrocardiogram (ECG) Findings [Baseline (screening) to Day 1]
- Number of Participants with Clinically Significant Abnormal Changes from Baseline in Vital Signs [Baseline (Day 1) to Day 11]
- Cmax of Sotorasib [Day 6 to Day 8]
- AUClast of Sotorasib [Day 6 to Day 8]
- AUCinf of Sotorasib [Day 6 to Day 8]
Eligibility Criteria
Criteria
Inclusion criteria:
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Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
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Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
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Females of nonchildbearing potential
Exclusion criteria:
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Inability to swallow oral medication or history of malabsorption syndrome.
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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.
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Poor peripheral venous access.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Covance Clinical Research Unit - Daytona Beach | Daytona Beach | Florida | United States | 32117-5116 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20200426