Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: AMG 510; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05581992

20190320

Details and patient eligibility

About

The primary objective of this study is to evaluate the PK profile of AMG 510 alone and in combination with omeprazole in healthy participants.

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects or female participants, 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

AMG 510 + Omeprazole

Experimental group

Description:

Participants will receive AMG 510 on Day 1, daily doses of omeprazole on Days 4 to 8, and a single dose of both omeprazole and AMG 510 on Day 9.

Treatment:

Drug: Omeprazole

Drug: AMG 510