NCT05568082

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

An Open-label Study to Evaluate the Drug-drug Interaction Effect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AMG 510	Oral tablet
DRUG	Itraconazole	Oral capsule

Timeline

• Start date: 2019-12-03
• Primary completion: 2019-12-17
• Completion: 2019-12-17
• First posted: 2022-10-05
• Last updated: 2025-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study