Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
Study NCT ID:
NCT03921268
Status:
COMPLETED
Last Update Posted:
2019-06-21
First Post:
2019-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess Effect of Device and Formulation on Pharmacokinetics (PK) of AZD1402
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Randomized Open Label, 3-period, 3-treatment, Crossover Study to Assess the Effect of Inhalation Device and Formulation on Pharmacokinetics Following a Single Inhaled Dose of AZD1402 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate and compare the pharmacokinetics profiles of AZD1402 after oral inhalation as an inhalation powder and a nebuliser solution.
To further assess the safety and tolerability of single doses of AZD1402 in healthy volunteers.
To evaluate the taste characteristics of the test formulations.
To further assess the safety and tolerability of single doses of AZD1402 in healthy volunteers.
To evaluate the taste characteristics of the test formulations.
Detailed Description:
This study will be a randomized, open-label, 3-period, 3-treatment, single dose, single-center, crossover study. Eighteen healthy male and female subjects will be randomized in this study to ensure that at least 12 subjects are evaluable. A subject will be considered to be evaluable if the subject completes all 3 Treatment Periods with no important protocol deviations. Subjects will be randomized to 1 of 6 treatment sequences and will receive each of the 3 single dose treatments of AZD1402 listed below.
* Treatment A: Dose A estimated delivered dose of AZD1402 nebuliser solution administered via a nebuliser.
* Treatment B: Dose B estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
* Treatment C: Dose C estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
The study will comprise of:
* A Screening Period of up to 28 days before the first administration of AZD1402.
* Three Treatment Periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD1402 (Day -1) until at least 48 hours after dosing and discharged on Day 3.
* A Follow-up Visit 10 to 12 days after the last administration of AZD1402 in Treatment Period 3.
Each Treatment Period will be separated by a minimum washout period of 5 days between doses.
All subjects will sign an Informed Consent Form before they participate in any specific study related procedures. Subjects will attend a Screening Visit within 28 days before receiving their first dose of AZD1402. If they are eligible, they will return for Treatment Period 1 when they will have baseline assessments and receive 1 of 3 treatments in a randomized order. For each Treatment Period, the subjects will receive a single dose of Investigational Medicinal Product (IMP) in the morning of Day 1 and have further assessments for 48 hours after dosing.
* Treatment A: Dose A estimated delivered dose of AZD1402 nebuliser solution administered via a nebuliser.
* Treatment B: Dose B estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
* Treatment C: Dose C estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
The study will comprise of:
* A Screening Period of up to 28 days before the first administration of AZD1402.
* Three Treatment Periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD1402 (Day -1) until at least 48 hours after dosing and discharged on Day 3.
* A Follow-up Visit 10 to 12 days after the last administration of AZD1402 in Treatment Period 3.
Each Treatment Period will be separated by a minimum washout period of 5 days between doses.
All subjects will sign an Informed Consent Form before they participate in any specific study related procedures. Subjects will attend a Screening Visit within 28 days before receiving their first dose of AZD1402. If they are eligible, they will return for Treatment Period 1 when they will have baseline assessments and receive 1 of 3 treatments in a randomized order. For each Treatment Period, the subjects will receive a single dose of Investigational Medicinal Product (IMP) in the morning of Day 1 and have further assessments for 48 hours after dosing.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: