Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05476107
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2022-06-22
Brief Title:
SAD Study to Assess the Safety Tolerability PK and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects
Sponsor:
Applied Molecular Transport
Organization:
Applied Molecular Transport
Study Overview
Official Title:
A Phase 1 Study in up to 2 Parts to Assess the Safety Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State in Part 1 and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State in Optional Part 2 in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2022-07
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:
Phase 1 Study of the Safety Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126
Detailed Description:
A Phase 1 Study in up to 2 Parts to Assess the Safety Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State in Part 1 and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State in Optional Part 2 in Healthy Male and Female Subjects
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 |
|---|---|---|---|
| 2020-005779-11 | EUDRACT_NUMBER | None | None |