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ALXN2040

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 14, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

ALXN2040 · 1 trial · 1 indication

Phase 1 1
NCT05708573Potential Drug Interaction Between ALXN2040 and RosuvastatinHealthy Participants
COMPLETED20 Analytics
PHASE1COMPLETED
Potential Drug Interaction Between ALXN2040 and Rosuvastatin
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma drug concentration during a dosing interval (Cmax) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Area under the concentration-time curve from time zero to the time of the last observed/measured nonzero concentration (AUC0-last) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Time to reach Cmax (tmax) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

First-order rate constant of drug associated with the terminal portion of the curve (λz) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Percentage of AUC0-inf due to extrapolation from time of last quantifiable concentration to infinity (AUC%extrap) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Apparent total plasma clearance after extravascular administration (CL/F) of rosuvastatin
Up to 96 hours postdose

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Cmax of ALXN2040
Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

tmax of ALXN2040
Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Area under the concentration-time curve from time zero to 8 hours postdose (AUC0-8) of ALXN2040
Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]

To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.

Secondary Endpoints

Number of participants with adverse events (AEs)
Screening (Day -28 to -2) Up to Follow-up Visit (7 ± 2 days after the last dose of study intervention, or at early discontinuation from the study) [approximately 48 days]
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALParticipants will receive a single dose of rosuvastatin in the morning of Day 1 in Treatment Period 1. Following a washout period of 5 days, participants will receive ALXN2040 three times daily on Days 1 through 7 in treatment period 2.

Interventions

NameTypeDescription
RosuvastatinDRUGIn Treatment Period 1, participants will receive a single oral tablet of rosuvastatin in the morning of Day 1. In treatment period 2, on the morning of Day 4, participants will receive a single 20 mg dose of rosuvastatin (co-administered with the morning dose of ALXN2040).
ALXN2040DRUGIn Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Medically healthy participants with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory safety evaluation (hematology, biochemistry, coagulation, and u...

Countries:United States
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Frequently asked questions about ALXN2040

What is ALXN2040 used for?

ALXN2040 is an investigational small molecule being studied in healthy participants. It is not approved for any disease and is currently in Phase 1 clinical development. The only completed trial evaluated a potential drug interaction between ALXN2040 and rosuvastatin in healthy volunteers.

Who makes ALXN2040?

ALXN2040 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this investigational small molecule, with one completed Phase 1 trial in healthy participants.

What phase is ALXN2040 in?

ALXN2040 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is ALXN2040 in?

ALXN2040 has one completed clinical trial, NCT05708573, titled 'Potential Drug Interaction Between ALXN2040 and Rosuvastatin'. This Phase 1 study enrolled 20 healthy participants in the United States and was not randomized or blinded.

Is ALXN2040 the same as any other drug?

No alternative names for ALXN2040 have been disclosed. It is identified solely by the code name ALXN2040 in clinical trial records, and no other names are associated with this investigational small molecule.