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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05568082
Collaborator
(none)
14
1
1
14
30.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Dec 3, 2019
Actual Primary Completion Date :
Dec 17, 2019
Actual Study Completion Date :
Dec 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMG 510 + Itraconazole

Drug: AMG 510
Oral tablet

Drug: Itraconazole
Oral capsule

Outcome Measures

Primary Outcome Measures

  1. Maximum Observed Plasma Concentration (Cmax) of AMG 510 [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 [Day 1 and Day 6]

  3. AUC from Time Zero to Infinity (AUCinf) of AMG 510 [Day 1 and Day 6]

Secondary Outcome Measures

  1. 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.

  2. Cmax of AMG 510 Metabolite M24 [Day 1 and Day 6]

  3. AUClast of AMG 510 Metabolite M24 [Day 1 and Day 6]

  4. AUCinf of AMG 510 Metabolite M24 [Day 1 and Day 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Covance Clinical Research Unit, Inc Daytona Beach Florida United States 32117

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT05568082
Other Study ID Numbers:
  • 20190318
First Posted:
Oct 5, 2022
Last Update Posted:
Oct 5, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amgen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2022