AZD4831 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 2 to day 8 and day 14

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called AZD4831 in two different versions to see how well each is absorbed by the body. Healthy volunteers will take each version of the drug at different times. Researchers will measure how much of the drug enters the bloodstream to determine which version is better absorbed. AZD4831 is being developed as a potential treatment for heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 2 to day 8 and day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 2 to day 8 and day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2 to day 8 and day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under plasma concentration-time curve from zero to infinity (AUCinf)

Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)

Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)

+6 more

Secondary study objectives

Number of participants with Adverse Events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sequence 2 (Formulation B + Formulation A)Experimental Treatment1 Intervention

Participants will receive a single oral dose of Treatment 2: Formulation B followed by a washout period of at least 14 days from first dose of AZD4831. After the washout period, participants will receive a single oral dose of Treatment 1 Formulation A.

Group II: Sequence 1 (Formulation A + Formulation B)Experimental Treatment1 Intervention

Participants will receive a single oral dose of Treatment 1: Formulation A followed by a washout period of at least 14 days from first dose of AZD4831. After the washout period, participants will receive a single oral dose of Treatment 2: AZD4831 Formulation B.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD4831

2022

Completed Phase 3

~990

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