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

Amgen

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Itraconazole

Drug: AMG 510

Study type

Interventional

Funder types

Industry

Identifiers

NCT05568082

20190318

Details and patient eligibility

About

The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of AMG 510 administered alone and in combination with itraconazole 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 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.