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Cohort 1 (healthy volunteers) for Type 2 Diabetes

Phase 1

Waitlist Available

Led By Esther Yoon, MD

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 to day 3

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 3

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events (AEs), and Serious Adverse Events (SAEs)

Secondary outcome measures

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)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4 (healthy volunteers - food effect)Experimental Treatment2 Interventions

One of the Part 1 cohorts (planned for Cohort 6, can be updated pending emerging data) will continue into the food-effect part after a washout period. This part will be initiated after SRC review of all available data from preceding cohorts in this study.

Group II: Cohort 3 (healthy Chinese volunteers)Experimental Treatment2 Interventions

The planned number of Chinese cohorts is 1, but more than 1 cohort may be included if it is considered necessary to repeat a dose level or if additional dose steps are required. No sentinel dosing will be performed for the Chinese cohort.

Group III: Cohort 2 (healthy Japanese volunteers)Experimental Treatment2 Interventions

The planned number of Japanese cohorts is 1, but more than 1 cohort may be included if the SRC considers it necessary to repeat a dose level or if additional dose steps are required. No sentinel dosing will be performed for the Japanese cohort.

Group IV: Cohort 1 (healthy volunteers)Experimental Treatment2 Interventions

The planned number of cohorts is up to 6 cohorts; additional cohorts may be included if it is considered necessary to repeat a dose level or if additional dose steps are required for safety purposes. Six subjects will receive AZD0186, and two subjects will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,871 Total Patients Enrolled

ParexelIndustry Sponsor

303 Previous Clinical Trials

100,795 Total Patients Enrolled

Esther Yoon, MDPrincipal InvestigatorPAREXEL Early Phase Clinical Unit-Los Angeles

5 Previous Clinical Trials

163 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186

2022. "A Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05694741.