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CompletedNCT05568082Updated Mar 5, 2025

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

A Phase 1 interventional study of AMG 510 and Itraconazole in Healthy Participants, sponsored by Amgen. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Amgen · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Dec 2019, 6 years 9 months ago, and no results have been posted to the registry.
  • Registered 2 years 10 months after the study started (first participant enrolled Dec 2019, registered Oct 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • Healthy participants
  • AMG 510
  • Itraconazole
03

In context

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    AMG 510 + Itraconazole

    Drug: AMG 510 · Drug: Itraconazole

Interventions

  • DrugAMG 510

    Oral tablet

  • DrugItraconazole

    Oral capsule

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of AMG 510

    Time frame: Day 1 and Day 6

  2. Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510

    Time frame: Day 1 and Day 6

  3. AUC from Time Zero to Infinity (AUCinf) of AMG 510

    Time frame: Day 1 and Day 6

Secondary outcomes

  1. Number of Participants with an Adverse Event (AE)

    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.

    Time frame: Day 1 to Day 8

  2. Cmax of AMG 510 Metabolite M24

    Time frame: Day 1 and Day 6

  3. AUClast of AMG 510 Metabolite M24

    Time frame: Day 1 and Day 6

  4. AUCinf of AMG 510 Metabolite M24

    Time frame: Day 1 and Day 6

07

Study locations

1 site
  • Covance Clinical Research Unit, Inc
    Daytona Beach, Florida 32117, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05568082
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Oct 5, 2022
Start date
Dec 3, 2019
Primary completion
Dec 17, 2019
Completion
Dec 17, 2019
Last update
Mar 5, 2025

Study contacts

MD
study director · Amgen

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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