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

Phase 1

Completed

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

• Registration Number: NCT05568082
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-03
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMG 510 + Itraconazole	AMG 510	-
AMG 510 + Itraconazole	Itraconazole	-

Primary Outcome Measures

Name	Time	Method
AUC from Time Zero to Infinity (AUCinf) of AMG 510	Day 1 and Day 6
Maximum Observed Plasma Concentration (Cmax) of AMG 510	Day 1 and Day 6
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 6

Secondary Outcome Measures

Name	Time	Method
Cmax of AMG 510 Metabolite M24	Day 1 and Day 6
AUClast of AMG 510 Metabolite M24	Day 1 and Day 6
Number of Participants with an Adverse Event (AE)	Day 1 to Day 8	An adverse event 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.
AUCinf of AMG 510 Metabolite M24	Day 1 and Day 6

Trial Locations

Locations (1)

Covance Clinical Research Unit, Inc; 🇺🇸 Daytona Beach, Florida, United States