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Completed

NCT Number: NCT05568082

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMG 510

Drug

Oral tablet

Itraconazole

Drug

Oral capsule

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)

    Time frame: 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.

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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