A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT05599828

Collaborator

(none)

Enrollment

Location

Arm

1.9

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the PK of AMG 510 alone and in combination with either famotidine or omeprazole in healthy participants under fed conditions.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: AMG 510 Drug: Omeprazole Drug: Famotidine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-label Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics of AMG 510 in Healthy Subjects Under Fed Conditions

Actual Study Start Date :

Jul 17, 2020

Actual Primary Completion Date :

Sep 13, 2020

Actual Study Completion Date :

Sep 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMG 510 + Omeprazole + Famotidine Participants will receive AMG 510 on Day 1, famotidine on Day 3, AMG 510 and famotidine on Day 4, omeprazole on Days 6 through 10, and omeprazole and AMG 510 on Day 11.	Drug: AMG 510 Oral Tablet Other Names: Sotorasib Drug: Omeprazole Capsule Drug: Famotidine Tablet

Arm

Intervention/Treatment

Experimental: AMG 510 + Omeprazole + Famotidine

Participants will receive AMG 510 on Day 1, famotidine on Day 3, AMG 510 and famotidine on Day 4, omeprazole on Days 6 through 10, and omeprazole and AMG 510 on Day 11.

Drug: AMG 510

Oral Tablet

Other Names:

Sotorasib

Drug: Omeprazole

Capsule

Drug: Famotidine

Tablet

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of AMG 510 [Day 1, Day 4, Day 11]
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510 [Day 1, Day 4, Day 11]
AUC from time Zero to Infinity (AUCinf) of AMG 510 [Day 1, Day 4, Day 11]

Secondary Outcome Measures

Number of Participants with an Adverse Event (AE) [Day 1 to Day 13]
Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 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.