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

Healthy Participants Clinical Trial

Official title:

An Open-label, Randomized, 2-Period, 2-Treatment Crossover Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571163
• Other study ID #: 20190500
• Status: Completed
• Phase: Phase 1
• Start date: March 6, 2020
• Est. completion date: June 14, 2020

Study information

• Verified date: September 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 14, 2020
• Est. primary completion date: June 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• AMG 510
Tablets

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc 1341 W Mockingbird Ln, Ste 200E	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of AMG 510		Day 1 and Day 4
Primary	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
Primary	Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510		Day 1 and Day 4
Secondary	Number of Participants with an Adverse Event (AE)	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 .	Day 1 to Day 6

External Links

•   AmgenTrials clinical trials website