Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002141
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
Sponsor:
Burroughs Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
Status:
COMPLETED
Status Verified Date:
1994-10
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 assess the safety of single oral doses of 1592U89 abacavir succinate ABC administered to HIV-positive individuals To determine the pharmacokinetics of 1592U89 after single oral doses To determine the effects of food on the bioavailability of 1592U89
Detailed Description:
Patients are randomized in a double-blinded manner with 12 patients entering the treatment arm and 6 patients entering the control arm Patients in the treatment arm receive 6 single escalating doses of 1592U89 separated by at least a 6-day washout period Patients in the control arm receive 6 single oral doses of placebo at least 6 days apart The second and third doses of 1592U89 are equivalent During these doses investigators study the effects of food on the pharmacokinetics of 1592U89 by giving half of the patients the second dose with a standardized high-fat breakfast and giving the other half the dose in a fasted state During the third dose patients are crossed over so that patients who received the second dose with a meal now receive it in a fasted state and vice versa Following the sixth dose investigators break the blind Patients who received 1592U89 take a seventh dose in solution form and return for follow-up at least 7 days later patients who received placebo receive no further treatment or follow-up Serial blood and urine samples are collected before and after each administration of 1592U89 or placebo for determination of plasma and urine concentrations of 1592U89 and investigators monitor patients closely for adverse events or abnormal laboratory test findings
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 |
|---|---|---|---|
| 001 | None | None | None |