Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040274
Status:
COMPLETED
Last Update Posted:
2005-07-19
First Post:
2002-06-24
Brief Title:
A Study of DPC 817 in HIV-Infected Males
Sponsor:
Pharmasset
Organization:
Pharmasset
Study Overview
Official Title:
A Placebo-Controlled Dose-Escalation Study in HIV-1 Infected Subjects to Characterize the Safety Tolerability and Pharmacokinetics of Single Oral Doses of DPC 817
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate DPC 817 The safety dosages and how the body responds to the drug will be studied
Detailed Description:
The study will consist of two parts Patients in Part A will receive a single dose of DPC 817 on two separate occasions and a placebo a solution or tablet without the drug on one occasion Patients in Part B will receive two separate doses of DPC 817 Patients will be admitted to the clinical study unit the day before dosing Day -1 and remain there for at least 48 hours after taking the study drug Patients will return to the clinical study unit on Day 8 and Day 28 following the dose in the last treatment period During the study there will be medical and medication histories taken physical examinations vital sign measurements and routine clinical laboratory tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None