Ignite Creation Date:
2024-05-06 @ 3:50 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02381496
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2015-03-03
Brief Title:
A Study to Assess the Tolerability Safety Pharmacodynamics and Pharmacokinetics of Ascending Single Doses Including Food Interaction and Ascending Multiple Doses of ACT-453859 and Multiple Doses of Setipiprant ACT-129968
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Three-part Study to Assess the Tolerability Safety Pharmacodynamics and Pharmacokinetics of Ascending Single Doses Including Food Interaction of ACT-453859 in Healthy Male Subjects of Ascending Multiple Doses of ACT-453859 in Healthy Male and Female Subjects and of Multiple Doses of Setipiprant ACT-129968 in Healthy Male and Female 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:
This is a three-part study to assess the tolerability safety pharmacodynamics and pharmacokinetics of ascending single doses including food interaction of ACT-453859 in healthy male subjects of ascending multiple doses of ACT-453859 in healthy male and female subjects and of multiple doses of setipiprant ACT-129968 in healthy male and female subjects
Detailed Description:
Part A of this study is a single-center randomized double-blind placebo-controlled single-ascending dose SAD design in healthy male subjects In each cohort eight subjects will be randomized as follows
Six male subjects will receive a single oral dose of ACT-453859 under fasted conditions
Two male subjects will receive matching placebo under fasted conditions
The doses of ACT-453859 were 1 3 10 30 100 300 and 800 mg Subjects in only one cohort 100 mg dose cohort will come back for a second period of treatment under fed conditions
Part B is a single-center randomized double-blind placebo-controlled multiple-ascending dose MAD design in healthy male and female of subjects
In each of 3 cohorts eight subjects will be randomized to receive multiple doses of ACT-453859 or placebo once a day for 7 days as follows
Three male subjects will receive ACT-453859
Three female subjects will receive ACT-453859
One male subject will receive matching placebo
One female subject will receive matching placebo
The doses of ACT-453859 will be 10 100 and 800 mg per day
Part C is a single-center and open-label design consisting of multiple oral doses of setipiprant given in a sequential design in healthy male and female subjects
Eight subjects will be randomized to receive multiple doses of setipiprant for 7 days only a single dose on Day 7 in Treatment Period I TPI and Treatment Period II TPII as follows
Four male subjects will receive setipiprant 500 mg twice a day bid in TPI and 1000 mg bid in TPII
Four female subjects will receive setipiprant 500 mg bid in TPI and 1000 mg bid in TPII
Six male subjects will receive a single oral dose of ACT-453859 under fasted conditions
Two male subjects will receive matching placebo under fasted conditions
The doses of ACT-453859 were 1 3 10 30 100 300 and 800 mg Subjects in only one cohort 100 mg dose cohort will come back for a second period of treatment under fed conditions
Part B is a single-center randomized double-blind placebo-controlled multiple-ascending dose MAD design in healthy male and female of subjects
In each of 3 cohorts eight subjects will be randomized to receive multiple doses of ACT-453859 or placebo once a day for 7 days as follows
Three male subjects will receive ACT-453859
Three female subjects will receive ACT-453859
One male subject will receive matching placebo
One female subject will receive matching placebo
The doses of ACT-453859 will be 10 100 and 800 mg per day
Part C is a single-center and open-label design consisting of multiple oral doses of setipiprant given in a sequential design in healthy male and female subjects
Eight subjects will be randomized to receive multiple doses of setipiprant for 7 days only a single dose on Day 7 in Treatment Period I TPI and Treatment Period II TPII as follows
Four male subjects will receive setipiprant 500 mg twice a day bid in TPI and 1000 mg bid in TPII
Four female subjects will receive setipiprant 500 mg bid in TPI and 1000 mg bid in TPII
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