Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT00950105
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2009-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)
Sponsor:
Ferring Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Oral CPSI-2364 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2012-08
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 will be conducted in healthy male or female subjects using a double-blind, randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3 healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3 to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg, 90 mg, and 270 mg.Safety will be evaluated throughout the study and include physical examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed repeatedly over the 24-hour observation period. Venous blood samples will be taken at specified intervals and tested for the presence of CPSI-2364.
Detailed Description:
This study will be conducted in healthy male or female subjects using a double-blind, randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3 healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3 to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg, 90 mg, and 270 mg. In Cohort 1 (1 mg) and Cohort 2 (10 mg), the three subjects will all be dosed on the same day, with at least 60 minute intervals between dosing. In Cohorts 3 to 5, the first two subjects of each cohort (one active, one placebo) will receive their drug on the same day with at least a 60-minute interval between dosing, with the remainder of the cohort being dosed the next day once these subjects have been assessed. Safety labs, physical examination findings, and adverse events available up to and including Day 5 data of each cohort will be reviewed by the Investigator, the Study Manager, and the Sponsor (or designee) in order to determine the progression of dose escalation. Subjects will not be enrolled in the next higher cohort until the dose in the preceding cohort is deemed safe and tolerable. Doses will continue to be escalated in subsequent groups until a maximum tolerated dose (MTD) is reached, or until a top dose of 270 mg is reached, whichever is sooner. Intermediate and repeat dose levels may be administered in addition to or in place of the planned dose levels, if it is deemed appropriate to increase the safety or scientific value of this Phase 1 exploratory study.Safety will be evaluated throughout the study and include physical examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed repeatedly over the 24-hour observation period.Venous blood samples will be taken at specified intervals and tested for the presence of CPSI-2364.
Study Oversight
Has Oversight DMC:
False
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?: