Study to Evaluate the Drug-drug Interactions Between Metformin and AMG 510 in Healthy Participants

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AMG 510; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05550129

20190317

Details and patient eligibility

About

The primary objectives of this study are to evaluate the effect of AMG 510 on the pharmacokinetics (PK) of metformin in healthy participants and to evaluate the effect of metformin on the PK of AMG 510 in healthy participants.

Enrollment: 13 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
2. Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.
3. Females of nonchildbearing potential.

Exclusion criteria

1. Inability to swallow oral medication or history of malabsorption syndrome.
2. 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.
3. Poor peripheral venous access.
4. 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 participant 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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13 participants in 1 patient group

AMG 510 + Metformin

Experimental group

Treatment:

Drug: Metformin

Drug: AMG 510