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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00950105
• Date of registration: 29/07/2009
• Prospective Registration: No
• Primary sponsor: Ferring Pharmaceuticals
• Public title: Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00950105
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Phillip Leese, MD
• Affiliation: Quintiles Phase I unit, Overland Park, KS

Key inclusion & exclusion 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;

- have no relevant food allergies (e.g., eggs or other components of standard clinic
meals); and

- must have signed the informed consent document prior to performance of any study
related procedures.

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);

- subject has donated plasma or blood within 30 days prior to the first dose of study
medication or has a history of blood donation of more than 500 mL within 3 months
prior to dosing;

- use of any prescription medications/products, except hormonal contraceptives, within
14 days prior to study entry, unless deemed acceptable by the Investigator;

- use of any over-the-counter (OTC) or nonprescription preparation (including minerals
and phytotherapeutic/herbal/plant-derived preparations), within 14 days prior to dose
administration, with the exception of ibuprofen and acetaminophen used at recommended
doses. For acetaminophen a maximum of 1500 mg per day and no more than 3 g per week,
will be allowed for the treatment of headache or other pain;

- any subject who does not meet the conditions for prior and concomitant treatments
described in Section 8.8 Prior and Concomitant Therapy of this protocol;

- has taken any other investigational drug during the 30 days prior to Day -1;

- has any condition(s) that in the Investigator's opinion would: a) warrant exclusion
from the study or b) prevent the subject from completing the study; or

- unable to understand verbal and/or written English or any other language in which a
certified translation of the informed consent is available.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: CPSI-2364 or placebo

Primary Outcome(s)

Safety and tolerability of CPSI-2364 [Time Frame: 7 days]

Secondary Outcome(s)

Pharmacokinetic profile of a single administration of oral CPSI-2364 [Time Frame: 7 days]

Secondary ID(s)

2364-CD-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors