A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: AMG 510

Study type: Interventional

Funder types: Industry

Identifiers

NCT05571163

20190500

Details and patient eligibility

About

The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.

Enrollment: 13 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects or healthy female between 18 and 55 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

• 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.
• Inability to swallow oral medication or history of malabsorption syndrome.
• Poor peripheral venous access.
• History of significant 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

13 participants in 2 patient groups

Treatment Sequence AB

Experimental group

Description:

Participants will be administered AMG 510 in the following order: Period 1 (treatment A) - AMG 510 as oral tablets. Period 2 (treatment B) - AMG 510 as tablets dispersed in water.

Treatment:

Drug: AMG 510

Treatment Sequence BA

Experimental group

Description:

Participants will be administered AMG 510 in the following order: Period 1 (treatment B) - AMG 510 as tablets dispersed in water. Period 2 (treatment A) - AMG 510 as oral tablets.

Treatment:

Drug: AMG 510