Ignite Creation Date:
2024-05-06 @ 2:21 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02029482
Status:
COMPLETED
Last Update Posted:
2014-01-08
First Post:
2014-01-06
Brief Title:
Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACT-128800 in Healthy Subjects
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Single-center Double-blind Placebo-controlled Randomized Parallel-group Up-titration Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Increasing Doses of ACT-128800 in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2014-01
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 was a single-center randomized double-blind placebo-controlled up-titration Phase 1 study Sixteen subjects in two groups at least 40 of subjects of either male or female sex with 12 subjects in the active treatment group with an up-titration scheme from 10 to 100 mg and 4 subjects in the placebo treatment group Subjects were administered ascending doses of ACT-128800placebo once daily for 3 days at each dose level 10 mg 20 mg 40 mg 60 mg 80 mg and 100 mg
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