Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01877629
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2013-06-12
Brief Title:
Clinical Study to Assess the Pharmacokinetics Safety and Tolerability of ACT-129968 in Healthy Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Single-center Open-label Two-period Two-treatment Crossover Single-dose Study in Healthy Female and Male Subjects to Assess the Pharmacokinetics Safety and Tolerability of Two Different Formulations of ACT-129968
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:
To explore the pharmacokinetics PK of a single dose of two different formulations of ACT-129968 ie tablet versus capsule and to evaluate the safety and tolerability of a single dose of two different formulations of ACT-129968 ie tablet versus capsule
Detailed Description:
A total of 10 female and 10 male healthy subjects will be enrolled and will attend two treatment periods separated by a 7-9 day washout Over these two periods two formulations of ACT-129968 Treatment A two capsules 250 mg each Treatment B one tablet 500 mg will be administered in the sequence AB or BA to 10 subjects 5 females and 5 males per sequence as determined by randomization
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