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

Type 2 Diabetes Clinical Trial

Official title: A Phase 1 Randomized, Single-blind, Placebo-controlled, First-in-Human and Sequential Group Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD0186 Following Single Ascending Doses Via Oral Administration

Status Terminated

Clinical Trial Summary

This study will assess the safety, tolerability, and pharmacokinetics of AZD0186 following single ascending doses (SAD) via oral administration in healthy adult participants.

Clinical Trial Description

This is a Phase 1, First-in-Human (FIH), randomized, single-blind, sponsor-open, placebo-controlled, SAD sequential group design study.

This study consists of four parts: Part 1, Part 2, Part 3, and Part 4.

The study will comprise of the following:

Part 1, Part 2, Part 3, and Part 4:

• A Screening Period of maximum 28 days.

• A Treatment Period during which subjects will be resident at the Clinical Unit from 2 days before IMP (Investigational Medicinal Product) administration (Day -2) until at least 48 hours after IMP administration; discharged on Day 3.

Part 4:

• A second Treatment Period during which subjects will be resident at the Clinical Unit from the day of the Follow-up Visit (Day 7 ±1 days after the last IMP dose) until at least 48 hours after the second IMP administration; discharged on Day 10.

Part 1, Part 2, Part 3, and Part 4:

• A Follow-up Visit after 7 (Part 1, Part 2, and Part 3) or 14 (Part 4) ±1 day after the last IMP dose. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT05694741
• Study type: Interventional
• Source: AstraZeneca
• Status: Terminated
• Phase: Phase 1
• Start date: December 20, 2022
• Completion date: May 10, 2023