Sequence 2 (Formulation B + Formulation A) for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Brooklyn, MD
Healthy Subjects (HS)
AZD4831 - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

A study to assess the relative bioavailability and safety of different formulations of AZD4831 in fasted state in healthy volunteers.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

9 Primary · 1 Secondary · Reporting Duration: Day 1, Day 2 to Day 8 and Day 14

Day 14
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)
Last observed (quantifiable) concentration (Clast)
Maximum observed plasma (peak) drug concentration (Cmax)
Relative bioavailability (Frel)
Terminal rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve (λz)
Time of last observed (quantifiable) concentration (tlast)
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Day 14
Number of participants with Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

2 Treatment Groups

Sequence 2 (Formulation B + Formulation A)
1 of 2
Sequence 1 (Formulation A + Formulation B)
1 of 2
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Sequence 2 (Formulation B + Formulation A) · No Placebo Group · Phase 1

Sequence 2 (Formulation B + Formulation A)
Drug
Experimental Group · 1 Intervention: AZD4831 · Intervention Types: Drug
Sequence 1 (Formulation A + Formulation B)
Drug
Experimental Group · 1 Intervention: AZD4831 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD4831
2022
Completed Phase 1
~130

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, day 2 to day 8 and day 14
Closest Location: Research Site · Brooklyn, MD
1900First Recorded Clinical Trial
311 TrialsResearching Healthy Subjects (HS)
2948 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.