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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: AMG 510

• Registration Number: NCT05571163
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-06
• Primary Completion: 2020-06-14
• Study Completion: 2020-06-14
• Status Verified: 2022-09
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence AB	AMG 510	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 Sequence BA	AMG 510	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with an Adverse Event (AE)	Day 1 to Day 6	An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs .

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc 1341 W Mockingbird Ln, Ste 200E; 🇺🇸 Dallas, Texas, United States