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ALXN2050 Prototype

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 6, 2024

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

ALXN2050 Prototype · 1 trial · 1 indication

Phase 1 1
NCT05780645A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult ParticipantsHealthy Participants
COMPLETED80 Analytics
PHASE1COMPLETED
A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of ALXN2050
Up to 96 hours postdose
Time to Reach Cmax (Tmax) of ALXN2050
Up to 96 hours postdose
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2050
Up to 96 hours postdose

Secondary Endpoints

Number of Participants With Adverse Events (AEs)
Day 1 up to Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALRegimen A: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen B: Participants will receive Dose C ALXN2050 MR Prototype Tablet orally under fasted conditions. Optional Regimens C, D, E, and F
Cohort 2EXPERIMENTALRegimen G: Participants will receive Dose B (3 x Dose A) ALXN2050 IR Tablet orally under fasted conditions. Regimen H: Participants will receive Dose C ALXN2050 MR Prototype Mini-Tablet orally under fasted conditions. Optional Regimens: I, J, K, and L

Interventions

NameTypeDescription
ALXN2050 MR Prototype TabletDRUGParticipants will receive various doses of the MR Prototype Tablet orally.
ALXN2050 Immediate Release (IR) TabletDRUGParticipants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.
ALXN2050 MR Prototype Mini-TabletDRUGParticipants will receive various doses of the MR Prototype Mini-Tablet orally.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or non-pregnant, non-lactating healthy females. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematolog...

Countries:United Kingdom
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Frequently asked questions about ALXN2050 Prototype

What is ALXN2050 Prototype?

ALXN2050 Prototype is an investigational small molecule being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development. The drug has been studied in healthy adult participants, and one clinical trial has been completed.

What is ALXN2050 Prototype used for?

ALXN2050 Prototype is being studied for use in healthy participants. It is an investigational drug in Phase 1 clinical development, and no approved indications have been established. The completed trial focused on healthy adult volunteers.

Who makes ALXN2050 Prototype?

ALXN2050 Prototype is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this investigational small molecule drug.

What phase is ALXN2050 Prototype in?

ALXN2050 Prototype is in Phase 1 clinical development. It is an investigational drug and has not been approved. One Phase 1 clinical trial involving the drug has been completed.

What clinical trials is ALXN2050 Prototype in?

ALXN2050 Prototype has been studied in clinical trial NCT05780645, titled "A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants." This Phase 1 trial was completed in the United Kingdom.

Is ALXN2050 Prototype the same as ALXN2050?

ALXN2050 Prototype is a modified release prototype formulation of ALXN2050. The clinical trial NCT05780645 compared the pharmacokinetic profile of ALXN2050 modified release prototype formulations with an immediate release reference tablet in healthy adult participants.