Trial Results

Protocol
Available Languages: English
Statistical Analysis Plan
Available Languages: English

Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.

Study Identifier:
ALXN1840-HV-105
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN1840
  • Drug: Celecoxib
Date
Jul 2020 - Nov 2020
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 50 Years
Requirements Information
Sex
Female & Male
Age
18 - 50 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ALXN1840
  • Drug: Celecoxib
Date
Jul 2020 - Nov 2020
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 50 Years years
Requirements Information

Protocol Summary

This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of celecoxib.

Trial Locations

Location
Status
Location
Clinical Trial Site
Austin, Texas, United States, 78744
Status
N/A