Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)

Crohn's Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

• NCT number: NCT00950105
• Study type: Interventional
• Source: Ferring Pharmaceuticals
• Status: Completed
• Phase: Phase 1
• Start date: July 2009
• Completion date: October 2009