Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002329
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of MDL 28574A in HIV-Infected Patients
Sponsor:
Hoechst Marion Roussel
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Single and Multiple Oral Dose-Tolerance Study of Oral MDL 28574A Solution in HIV-Positive Patients
Status:
COMPLETED
Status Verified Date:
1995-05
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:
None
Brief Summary:
To characterize the safety profile of MDL 28574A following both acute and subchronic dosing in HIV-positive patients To determine the MTD of both acute and subchronic doses of this drug when administered as oral solution To determine the pharmacokinetic profile of MDL 28574A and castanospermine from which MDL 28574A is derived following both acute and subchronic dosing
Detailed Description:
In Part A of the study patients receive a single oral dose of MDL 28574A on day 1 and are followed through day 7 In Part B patients receive single daily doses of the drug on days 1 through 14 and are followed through day 21
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NDPR0002 | None | None | None |