Crohn's DiseasePhase 1NCT00950105
Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)
A Phase 1 study of Crohn's Disease, run by Ferring Pharmaceuticals at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- CPSI-2364 or placebo
- Keywords
- CPSI2364, Semapimod, Anti TNF alpha, Crohn's Disease, Safety, Tolerability, Pharmacokinetics
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPSI-2364 or placeboDrug
Also called semapimod
Single, oral dose of CPSI-2364 or placebo
| Study group | Role | What they receive |
|---|---|---|
| CPSI-2364 1 mg p.o. | Experimental | Single dose Receives: Drug: CPSI-2364 or placebo |
| CPSI-2364 10 mg p.o. | Experimental | single dose Receives: Drug: CPSI-2364 or placebo |
| CPSI-2364 30 mg p.o. | Experimental | single dose Receives: Drug: CPSI-2364 or placebo |
| CPSI-2364 90 mg | Experimental | single dose Receives: Drug: CPSI-2364 or placebo |
| CPSI-2364 270 mg p.o. | Experimental | single dose Receives: Drug: CPSI-2364 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CPSI-2364
Measured: 7 days
Secondary outcomes (1)
Pharmacokinetic profile of a single administration of oral CPSI-2364
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip Leese, MD, Principal investigator, Quintiles Phase I unit, Overland Park, KS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950105
- Sponsor's protocol ID
- 2364-CD-101
- Status last verified
- Aug 2012
- First submitted
- 29 Jul 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00950105
- Acronym / sponsor ID
- 2364-CD-101
- Conditions
- Crohn's Disease
- Keywords
- CPSI2364, Semapimod, Anti TNF alpha, Crohn's Disease, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CPSI-2364 1 mg p.o. | Experimental | Drug: CPSI-2364 or placeboSingle dose |
| CPSI-2364 10 mg p.o. | Experimental | Drug: CPSI-2364 or placebosingle dose |
| CPSI-2364 30 mg p.o. | Experimental | Drug: CPSI-2364 or placebosingle dose |
| CPSI-2364 90 mg | Experimental | Drug: CPSI-2364 or placebosingle dose |
| CPSI-2364 270 mg p.o. | Experimental | Drug: CPSI-2364 or placebosingle dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (17 listed)
- 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]) ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPSI-2364 or placeboAlso: semapimodSingle, oral dose of CPSI-2364 or placebo | Drug | CPSI-2364 1 mg p.o., CPSI-2364 10 mg p.o., CPSI-2364 270 mg p.o., CPSI-2364 30 mg p.o., CPSI-2364 90 mg |
Primary outcome
Safety and tolerability of CPSI-2364
Time frame: 7 days
1 secondary outcome
Pharmacokinetic profile of a single administration of oral CPSI-2364
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Leese, MD principal investigator
Quintiles Phase I unit, Overland Park, KS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Crohn's Disease, run by Ferring Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of CPSI-2364 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.