A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Sequence ABC Participants will be administered sotorasib orally in the following order: Period 1 - as 1 tablet (test 1) Period 2 - as 2 tablets (reference) Period 3 - as 1 tablet (test 2) |
Drug: Sotorasib
Oral Tablet
Other Names:
|
| Experimental: Treatment Sequence BAC Participants will be administered sotorasib orally in the following order: Period 1 - as 2 tablets (reference) Period 2 - as 1 tablet (test 1) Period 3 - as 1 tablet (test 2) |
Drug: Sotorasib
Oral Tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib [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 [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 [Day 1 and Day 4 of Overall Study]
Secondary Outcome Measures
- Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) [Day 1 to Day 9]
Clinically significant abnormal laboratory values, vital signs and 12-lead electrocardiogram (ECG) findings as assessed by the Investigator will be recorded as adverse events.
- Period 3: Cmax of Sotorasib [Day 7 to Day 9]
To evaluate the PK of sotorasib administered orally with a high-fat meal.
- Period 3: AUClast of Sotorasib [Day 7 to Day 9]
To evaluate the PK of sotorasib administered orally with a high-fat meal.
- Period 3: AUCinf of Sotorasib [Day 7 to Day 9]
To evaluate the PK of sotorasib administered orally with a high-fat meal.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Labcorp Clinical Research Unit - Daytona Beach | Daytona Beach | Florida | United States | 32117-5116 |
| 2 | Miami Research Associates LLC - Main Campus / Late Phase | South Miami | Florida | United States | 33143-5026 |
| 3 | Labcorp Clinical Research Unit - Dallas | Dallas | Texas | United States | 75247-4989 |
| 4 | Labcorp Clinical Research Unit - Madison | Madison | Wisconsin | United States | 53704-2526 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20210088