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A Study to Evaluate the Drug-drug Interaction Effect of Rifampin on the Pharmacokinetics of AMG 510 in Healthy Participants

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05577624
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
26
Actual Duration (Days)
16.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of AMG 510 alone and in combination with rifampin 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 Rifampin, a CYP3A4 Inducer, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Actual Study Start Date :
Nov 5, 2019
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMG 510 + Rifampin

Drug: AMG 510
Oral tablet

Drug: Rifampin
Oral capsule

Outcome Measures

Primary Outcome Measures

  1. Maximum Plasma Concentration (Cmax) of AMG 510 [Days 1, 3 and 8]

  2. Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510 [Days 1, 3 and 8]

  3. AUC from Time Zero to Infinity (AUCinf) of AMG 510 [Days 1, 3 and 8]

Secondary Outcome Measures

  1. Number of Participants with an Adverse Event (AE) [Day 1 to Day 20]

    An AE 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 [Days 1, 3 and 8]

  3. AUClast of AMG 510 Metabolite M24 [Days 1, 3 and 8]

  4. AUCinf of AMG 510 Metabolite M24 [Days 1, 3 and 8]

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 participants or female participants, 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 3402 Kinsman Boulevard Madison Wisconsin United States 53704

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:
NCT05577624
Other Study ID Numbers:
  • 20190319
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 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
Healthy participants
AMG 510
Rifampin
Additional relevant MeSH terms:
Rifampin

Study Results

No Results Posted as of Oct 13, 2022