Phase 1
Completed N=54
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Source: ClinicalTrials.gov NCT04526210 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Bupropion With and Without the Coadministration of ALXN1840 — 98.64; 98.02 nanograms (ng)/milliliter (mL)
Summary
This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6 (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of bupropion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Bupropion With and Without the Coadministration of ALXN1840 |
98.64; 98.02 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) of Bupropion With and Without the Coadministration of ALXN1840 |
1021; 1010 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUCinf) of Bupropion With and Without the Coadministration of ALXN1840 |
1049; 1039 | — |
| SECONDARY Cmax of Hydroxybupropion With and Without the Coadministration of ALXN1840 |
286.5; 284.3 | — |
| SECONDARY AUCt of Hydroxybupropion With and Without the Coadministration of ALXN1840 |
11900; 11560 | — |
| SECONDARY AUCinf of Hydroxybupropion With and Without the Coadministration of ALXN1840 |
11960; 11630 | — |
| SECONDARY Cmax of Plasma Total Molybdenum With Coadministration of Bupropion |
325.6 | — |
| SECONDARY AUCt of Plasma Total Molybdenum With Coadministration of Bupropion |
15010 | — |
| SECONDARY AUCinf of Plasma Total Molybdenum With Coadministration of Bupropion |
16130 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
8; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Adequate venous access in the left or right arm to allow the collection of blood samples.
- Body weight ≥ 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 (NCT04526210). 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.