Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04578028
Status:
COMPLETED
Last Update Posted:
2021-12-30
First Post:
2020-10-01
Brief Title:
A First in Human Study to Assess the Safety Tolerability and Pharmacokinetics of ONO-2808-01 in Healthy Participants
Sponsor:
Ono Pharmaceutical Co Ltd
Organization:
Ono Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomised Double Blind Placebo Controlled Single Centre Three-Part Study to Assess the Safety Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of ONO-2808 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-12
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:
This is a first in human study to determine the safety tolerability and pharmacokinetics of ONO-2808 in healthy adult participants The study will be conducted in 3 parts Part A a single-ascending dose part with an assessment of the potential food effects in non-Japanese adult participants Part B a single dose part to assess the effect of age in non-Japanese elderly participants and Part C a multiple-ascending dose part with ONO-2808 administered to healthy subjects
Detailed Description:
None
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 |
|---|---|---|---|
| 2019-004693-26 | EUDRACT_NUMBER | None | None |