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

Ferring Pharmaceuticals1 site in 1 country30 target enrollmentJuly 2009

ConditionsCrohn's Disease

InterventionsCPSI-2364 or placebo

DrugsCPSI-2364 or placebo

Overview

Phase: Phase 1
Intervention: CPSI-2364 or placebo
Conditions: Crohn's Disease
Sponsor: Ferring Pharmaceuticals
Enrollment: 30
Locations: 1
Primary Endpoint: Safety and tolerability of CPSI-2364
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

October 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects meeting all of the following criteria will be considered for admission to the study:
•male or female between 18 and 55 years old inclusive;
•for females, the following conditions are to be met: all female subjects must be confirmed as not pregnant via serum pregnancy test; females must be of non-childbearing potential (defined as either surgically sterile or at least 1 year postmenopausal); or female subjects of childbearing potential must use 2 of the 3 following acceptable birth control methods from the time specified prior to the study through 60 days following the last dose of study drug: intrauterine contraceptive device (IUD) in place for at least 2 months prior to study; barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening; stable hormonal contraceptive for at least 3 months prior to study;
•in good health as determined by the Investigator based on medical history, physical examination, ECG, and clinical laboratory tests;
•with a body mass index (BMI) of 19 to 30 kg/m2, inclusive;
•nonsmokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the administration of the study medication), subjects must have nicotine levels below those measured for smokers (less than 400 ng/mL);
•agrees to abstain from alcohol intake 48 hours before each administration of study agent and during inpatient portion of the study (Days -1 to 2);
•agrees to limit caffeine/methylxanthine (e.g., coffee, tea, chocolate, or caffeine-containing soft drinks) intake to less than 300 mg/day for the duration of the study (300 mg of caffeine is equal to approximately 3 cups of coffee or 6 cola drinks);
•agrees not to consume food or beverages containing grapefruit juice, Seville oranges, or quinine (e.g., tonic water) from 72 hours prior to study Day -1 until after the last PK sample is collected;
•capable of understanding and complying with the protocol; willing and able to adhere to the study visit schedule and other protocol requirements;

Exclusion Criteria

•currently have, or have a history of, disease or dysfunction of the renal, hepatic, pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system, that is clinically significant in the opinion of the Investigator;
•likely hypersensitivity or allergies to CPSI-2364, any components of CPSI-2364, or any drug within the same class of drug, minor drug allergies to a drug in other drug class may be approved by the Investigator if not considered of clinical relevance;
•any subject with a clinically significant mental or physical illness (in the opinion of the Investigator/Medical Advisor) within 1 year prior to the first dose, including a history of alcohol and/or drug abuse (as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition guidelines) within 1 year prior to the first dose of study medication;
•abnormal pre-admission vital signs, 12-lead ECGs, and urinanalysis which are considered clinically significant by the Investigator and Sponsor (or designee);
•abnormal clinical laboratory evaluations, particularly abnormal creatinine, calculated GFR (abnormal defined as \> 60 mL/min), and liver function tests. (Minor excursions from the normal range may be allowed if the clinical picture is otherwise normal and they are considered clinically insignificant by the Investigator and Sponsor \[or designee\]) ;
•any subject considering or scheduled to undergo any surgical procedure during the duration of the study;
•have an acute illness within 7 days prior to study agent administration or have had a hospitalization within 1 month prior to study agent administration;
•any subject who has received any known hepatic or renal clearance altering agents (eg, erythromycin, cimetidine, barbiturates, phenothiazines, or herbal/plant-derived preparations such as St. John's Wort, etc.) for a period of 90 days prior to the first dose of study medication;
•has a positive serology test for human immunodeficiency virus (HIV) antibodies, hepatitis A, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening;
•has a positive urine drug screen for ethanol or substances of abuse including cocaine, cannabinoids, phencyclidine, amphetamines, benzodiazepines, barbiturates, opiates, propoxyphene, and methadone at screening and check-in(s);