Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03710434
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2018-10-16
Brief Title:
AZD4635 Relative Bioavailability Study
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Open-Label Study to Assess the Pharmacokinetics and Relative Bioavailability of AZD4635 in Non-Smoking Healthy Male Subjects With the Option to Assess Food Effect pH Effect and Absolute Bioavailability
Status:
COMPLETED
Status Verified Date:
2020-05
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:
Rel Bio
Brief Summary:
To investigate the pharmacokinetics and relative bioavailability of AZD4635 solid oral formulation and compare with the nano-suspension reference formulation with the option to assess food effect pH effect and absolute bioavailability
Detailed Description:
This is a single centre phase 1 open-label randomised 2-part study to assess the pharmacokinetics and relative bioavailability of AZD4635 in non-smoking healthy male subjects with the option to assess food effect pH effect and absolute bioavailability It is planned to enrol 20 subjects who will participate in both parts of the study Subjects will receive a single-dose of AZD4635 in 6 dosing periods with a minimum washout of 9 days between doses
Part A is a 2-period randomised crossover study of single doses of AZD4635 Subjects will be randomised to receive 50mg AZD4635 nano-suspension reference or 50mg AZD4635 solid oral formulation in the fasted state
Part B is a 4-period open-label randomised crossover study of single doses of AZD4635 in the same subjects from Part A The treatments selected for Part B will depend on the outcome of interim analyses of AZD4635 exposure Subjects will receive 2 of the following 4 treatments in dosing periods 3 and 4
A single dose of AZD4635 solid oral formulation dose after a high fat meal
A single dose of AZD4635 solid oral formulation co-administered with a proton pump inhibitor PPI lansoprazole fasted state
A different single dose XX mg of AZD4635 solid oral formulation fasted state
Another different single dose YY mg of AZD4635 solid oral formulation fasted state
Periods 5 and 6 is a 2-period randomised crossover of two variants of AZD4635 solid oral formulation Subjects will be randomised to receive AZD4635 solid oral formulation variant 1 in the fasted state or AZD4635 solid oral formulation variant 2 in the fasted state In Periods 5 and 6 Part B an IV microtracer dose of 14C AZD4635 with solid oral formulation variant 1 will be administered
Part A is a 2-period randomised crossover study of single doses of AZD4635 Subjects will be randomised to receive 50mg AZD4635 nano-suspension reference or 50mg AZD4635 solid oral formulation in the fasted state
Part B is a 4-period open-label randomised crossover study of single doses of AZD4635 in the same subjects from Part A The treatments selected for Part B will depend on the outcome of interim analyses of AZD4635 exposure Subjects will receive 2 of the following 4 treatments in dosing periods 3 and 4
A single dose of AZD4635 solid oral formulation dose after a high fat meal
A single dose of AZD4635 solid oral formulation co-administered with a proton pump inhibitor PPI lansoprazole fasted state
A different single dose XX mg of AZD4635 solid oral formulation fasted state
Another different single dose YY mg of AZD4635 solid oral formulation fasted state
Periods 5 and 6 is a 2-period randomised crossover of two variants of AZD4635 solid oral formulation Subjects will be randomised to receive AZD4635 solid oral formulation variant 1 in the fasted state or AZD4635 solid oral formulation variant 2 in the fasted state In Periods 5 and 6 Part B an IV microtracer dose of 14C AZD4635 with solid oral formulation variant 1 will be administered
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003366-14 | EUDRACT_NUMBER | None | None |