NCT06531811

A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.

A Randomized, Open-label, Single-dose, 2-Treatment, 2-Period, Crossover Study to Assess the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the potential difference between pharmacokinetics (PK), safety, tolerability and device performance between the AZD8630 test formulation and the AZD8630 reference formulation.

Detailed description

This is a randomized, open-label, 2- treatment, 2- period study with a duration of approximately 6 weeks. The Study will comprise of: * A Screening period of 28 days, * Treatment Period 1 on Day 1 and Treatment Period 2 on Day 9 * A Follow-up visit within 7 days (± 2 days) after the last dose in Period 2. Participants will be randomized 1:1 to either Sequence 1 or Sequence 2. * Sequence 1: Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder). * Sequence 2: Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD8630 (test formulation) via test inhaler	Participants will receive AZD8630 via test inhaler.
DRUG	AZD8630 (reference formulation) via Monodose inhaler	Participants will receive AZD8630 via Monodose inhaler.
DEVICE	Test inhaler	Participants will receive AZD8630 via test inhaler.
DEVICE	Monodose inhaler	Participants will receive AZD8630 via Monodose inhaler.

Timeline

• Start date: 2024-08-06
• Primary completion: 2024-10-03
• Completion: 2024-10-03
• First posted: 2024-08-01
• Last updated: 2024-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study