Cohort 3 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Brooklyn, MD
Healthy Subjects (HS)+1 More
Acetaminophen - CombinationProduct
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

A study in healthy male and female participants of non-childbearing potential who are overweight or obese.

Eligible Conditions

  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Day 1, Day 15, Day 29 and at Follow up (Day 43)

Day 43
ADA titer
Prevalence and incidence of anti-drug antibodies (ADAs) to AZD6234
Day 43
Apparent total body clearance of drug from plasma (SC dosing only) (CL/F)
Apparent volume of distribution based on the terminal phase (SC dosing only) (Vz/F)
Area under plasma concentration-time curve from zero to infinity (AUCinf)
Area under the plasma concentration-time (AUClast)
Dose-normalized AUCinf (AUCinf/D)
Dose-normalized AUClast (AUClast/D)
Dose-normalized Cmax (Cmax/D)
Maximum observed plasma drug concentration (Cmax)
Terminal elimination half-life (t½λz)
Terminal rate constant (λz)
Time of last observed (quantifiable) concentration (tlast)
Time to reach maximum observed concentration (tmax)
Total body clearance of drug from plasma (IV dosing only) (CL)
Volume of distribution based on the terminal phase (IV dosing only) (Vz)
Day 43
Number of participants with AEs and Serious Adverse Events(SAE)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

8 Treatment Groups

Cohort 3
1 of 8
Cohort 5
1 of 8
Cohort 6
1 of 8
Cohort 4
1 of 8
Cohort 7
1 of 8
Cohort 1
1 of 8
Cohort 8
1 of 8
Cohort 2
1 of 8
Experimental Treatment

64 Total Participants · 8 Treatment Groups

Primary Treatment: Cohort 3 · Has Placebo Group · Phase 1

Cohort 3Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Cohort 5Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Cohort 6Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Cohort 4Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Cohort 7Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Cohort 1Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Cohort 8Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Cohort 2Experimental Group · 3 Interventions: Placebo, Acetaminophen, AZD6234 · Intervention Types: Drug, CombinationProduct, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Acetaminophen
2017
Completed Phase 4
~2160

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 15, day 29 and at follow up (day 43)
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 · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 55 years and have healthy veins for cannulation or repeated venipuncture.

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.