A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02039063|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2014
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: E6011 2 mg/kg Drug: E6011 5 mg/kg Drug: E6011 10 mg/kg Drug: E6011 15 mg/kg||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease|
|Actual Study Start Date :||May 14, 2014|
|Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||March 2018|
E6011 2 mg/kg
|Drug: E6011 2 mg/kg|
E6011 5 mg/kg
|Drug: E6011 5 mg/kg|
E6011 10 mg/kg
|Drug: E6011 10 mg/kg|
E6011 15 mg/kg
|Drug: E6011 15 mg/kg|
- Adverse events (AEs) as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Safety assessments include the following: AEs, laboratory test values (vasculitis marker), vital signs, body weight, physical examination, neurological examination, ECG, and chest x-ray.
- Laboratory assessments as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Clinical laboratory assessments will include hematology, clinical chemistry, urinalysis and other screening tests.
- Vital signs as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate.
- Electrocardiogram (ECG) as a measure of safety and tolerability [ Time Frame: Baseline and Week 12 ]Twelve-lead ECGs will be obtained as a measure of safety and tolerability.
- Pharmacokinetics (PK) profiles of repeated intravenous administration of E6011 [ Time Frame: Baseline and Week 12 ]PK parameters including area under the concentration-time curve (AUC) and maximum blood concentrations (Cmax), half life (T1/2), time to Cmax (Tmax) following repeated intravenous administration of E6011.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039063
|Nagoya, Aichi, Japan|
|Chikushino, Fukuoka, Japan|
|Kurume, Fukuoka, Japan|
|Asahikawa, Hokkaido, Japan|
|Nishinomiya, Hyogo, Japan|
|Kanazawa, Ishikawa, Japan|
|Morioka, Iwate, Japan|
|Sagamihara, Kanagawa, Japan|
|Tsu, Mie, Japan|
|Urazoe, Okinawa, Japan|
|Takatsuki, Osaka, Japan|
|Minato-ku, Tokyo, Japan|
|Shinjuku-ku, Tokyo, Japan|