Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511654
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2007-08-02
Brief Title:
28-day Repeat Dose and Drug Interaction Study With Orvepitant GW823296
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Parallel Group Single-Blind Randomised Placebo Controlled Study to Evaluate the Safety Tolerability and Pharmacokinetics of GW823296 and Its Effect on the Pharmacokinetics of Midazolam After Once-Daily Repeated Oral Doses in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-08
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 study is being conducted to obtain information on the safety and tolerability of repeated doses of GW823296 for 28 days in healthy male and female subjects In addition the pharmacokinetics of GW823296 will be evaluated to confirm the doses to be used in Phase II efficacy studies The effect of repeat dose RD of GW823296 on CYP3A4 enzyme activity will be investigated evaluating the pharmacokinetics of midazolam and urine 6--hydroxycortisolcortisol ratio
Detailed Description:
None
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