A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
|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 ]
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.|