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

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

Summary

This trial tests a new drug, AZD0186, on healthy adults to ensure it is safe and understand how the body processes it.

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

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

Primary study objectives

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

Secondary study objectives

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

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