Cohort 1 (healthy volunteers) for Type 2 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Glendale, CAType 2 DiabetesAZD0186 - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
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Study Summary

This trial tests a new drug's safety, side effects, and how it's absorbed in healthy adults.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Day 1 to Day 3

Day 3
Area under plasma concentration-time curve from zero to infinity (AUCinf)
Area under the plasma concentration-time curve from 0 to the last quantifiable concentration (AUClast)
Maximum observed concentration (Cmax)
Week 6
Adverse Events (AEs), and Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Cohort 1 (healthy volunteers)
1 of 4
Cohort 3 (healthy Chinese volunteers)
1 of 4
Cohort 4 (healthy volunteers - food effect)
1 of 4
Cohort 2 (healthy Japanese volunteers)
1 of 4

Experimental Treatment

72 Total Participants · 4 Treatment Groups

Primary Treatment: Cohort 1 (healthy volunteers) · Has Placebo Group · Phase 1

Cohort 1 (healthy volunteers)Experimental Group · 2 Interventions: AZD0186, Placebo · Intervention Types: Drug, Drug
Cohort 3 (healthy Chinese volunteers)Experimental Group · 2 Interventions: AZD0186, Placebo · Intervention Types: Drug, Drug
Cohort 4 (healthy volunteers - food effect)Experimental Group · 2 Interventions: AZD0186, Placebo · Intervention Types: Drug, Drug
Cohort 2 (healthy Japanese volunteers)Experimental Group · 2 Interventions: AZD0186, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 3

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,014 Previous Clinical Trials
240,372,593 Total Patients Enrolled
ParexelIndustry Sponsor
281 Previous Clinical Trials
96,504 Total Patients Enrolled
Esther Yoon, MDPrincipal InvestigatorPAREXEL Early Phase Clinical Unit-Los Angeles
5 Previous Clinical Trials
163 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

Does this investigation extend to geriatric individuals?

"This trial has set the lower age limit for eligibility at 18 years old and capped off the maximum age requirement at 55." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment capacity for this clinical trial?

"Correct. According to the information posted on clinicaltrials.gov, this medical study is accepting participants at present. This research was first made available on December 20th 2022 and the details were last updated on January 12th 2023. 72 people are needed for enrolment across 1 site location." - Anonymous Online Contributor

Unverified Answer

What risks do healthy volunteers face when joining Cohort 1?

"Due to the limited number of supporting data, Cohort 1 (healthy volunteers) are assessed as having a low safety rating – score one on our scale at Power. This is in line with Phase 1 trial standards." - Anonymous Online Contributor

Unverified Answer

Does this research initiative have any open positions?

"Affirmative. Clinicaltrials.gov provides evidence that this research effort, which was initially published on December 20th 2022, is currently recruiting participants. The trial requires 72 individuals to be enrolled from one site." - Anonymous Online Contributor

Unverified Answer

Am I eligible to partake in this investigation?

"This trial demands 72 participants, aged 18 to 55 years old who possess type 2 diabetes. Furthermore, all individuals must meet the following expectations: have provided signed and dated consent for this research; men or women of non-childbearing potential that weigh no less than 50 kgs and are within a BMI range from 18 - 32 inclusive; those partaking in Part Two need to be Japanese with both their parents and four grandparents being natively-born Japanese citizens, whereas Chinese subjects involved in Part Three require both of their parents and all 4 grandparents hailing from China (no more than 10 years spent abroad)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.