A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
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|ClinicalTrials.gov Identifier: NCT01525394|
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : March 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Refractory Solid Tumors Lymphomas||Drug: Lenvatinib Drug: Moxifloxacin 400 mg Drug: Placebos (matched to 4 mg and 10 mg lenvatinib capsules).||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||August 2011|
|Experimental: Lenvatinib Capsules||
32 mg will be administered orally as three 4 mg and two 10 mg capsules as a single dose.
Other Name: E7080
|Active Comparator: Moxifloxacin tablets||
Drug: Moxifloxacin 400 mg
Moxifloxacin 400 mg will be administered orally as one 400 mg tablet.
|Placebo Comparator: Placebos||
Drug: Placebos (matched to 4 mg and 10 mg lenvatinib capsules).
The Placebo dose will consist of three 4 mg and two 10 mg placebo capsules.
- To evaluate the potential for QT/QTc prolongation by 32 mg lenvatinib using a placebo control and moxifloxacin as the positive control. [ Time Frame: 2 months ]
- To evaluate the safety of lenvatinib in healthy subjects. [ Time Frame: 2 months ]
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): NCT01525394
|United States, Washington|
|Tacoma, Washington, United States, 98418|
|Study Director:||Robert Shumaker||Eisai Inc.|