Phase 1
Completed N=36
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
Source: ClinicalTrials.gov NCT04526197 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) Of Celecoxib With And Without The Coadministration Of ALXN1840 — 637.1; 567.4 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) Of Celecoxib With And Without The Coadministration Of ALXN1840 |
637.1; 567.4 | — |
| PRIMARY Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) Of Celecoxib With And Without The Coadministration Of ALXN1840 |
6406; 6482 | — |
| PRIMARY Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) Of Celecoxib With And Without The Coadministration Of ALXN1840 |
6743; 6869 | — |
| SECONDARY Cmax Of Molybdenum With Coadministration Of Celecoxib |
373.4; 82.44 | — |
| SECONDARY AUCt Of Molybdenum With Coadministration Of Celecoxib |
19240; 1796 | — |
| SECONDARY AUCinf Of Molybdenum With Coadministration Of Celecoxib |
20910; 2305 | — |
Eligibility Criteria
Inclusion Criteria
- Adequate venous access in the left or right arm to allow the collection of blood samples.
- Bodyweight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to upper limit of normal (ULN) of the reference range.
- Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > ULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QTc > 450 milliseconds (msec) for male participants or > 470 msec for female participants.
Data sourced from ClinicalTrials.gov (NCT04526197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.