Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01954615
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2013-09-27
Brief Title:
Single-ascending Oral Dose Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACT-281959 ACT-246475 in Healthy Male Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Single-center Double-blind Randomized Placebo-controlled Single-ascending Oral Dose and Food Interaction Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACT-281959 ACT-246475 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2018-07
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:
Study Part I is a single-ascending dose study Healthy male subjects to be included in the study and randomized in 6 dose groups Groups A-F 8 subjects per group Of the 8 subjects per group 6 subjects receive the investigational drug and 2 subjects receive matching placebo Study Part II is a 3-period crossover single dose study Nine healthy male subjects to be enrolled in one group Group G Each subject to receive 2 different formulations of the prodrug and one formulation of the active drug in a randomized sequence
Detailed Description:
Study Part I is a prospective single-center double-blind randomized placebo-controlled single-ascending dose Phase 1 study Approximately 48 healthy male subjects to be included in the study and randomized in 6 dose groups Groups A-F 8 subjects per group Of the 8 subjects per group 6 subjects are to receive the investigational drug and 2 subjects to receive matching placebo Study Part II is a prospective single-center open-label randomized 3-period crossover single dose Phase 1 study Nine healthy male subjects to be enrolled in one group Group G Each subject to receive 2 different formulations of the prodrug and one formulation of the active drug in a randomized sequence
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