Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Particip… (NCT02833831) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants
United States103 participantsStarted 2016-06-02
Plain-language summary
The primary objective of this study is to evaluate the effect of supratherapeutic exposures of ALS-008176 on the QT/ corrected QT interval (QTc) interval in healthy participants (Panel 2).
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in protocol
* A female participant must be of non-childbearing potential, defined as either: a) Postmenopausal- A postmenopausal state is defined as no menses for at least 12 months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (\> 40 International units per liter \[IU/L\] or International units/milliliter \[mIU/mL\]); b) Permanently sterile- Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy
* During the study and for a minimum of one spermatogenesis cycle (defined as approximately 90 days) after receiving the (last dose of) study drug, a male participant: a) who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example, condom with spermicidal foam/gel/film/cream/suppository); b) who is sexually active with a pregnant woman must use a condom; c) must agree not to donate sperm
* Female partners of male participants must either be surgically sterilized, postmenopausal (amenorrhea for a minimum of 1 year) or, if …
What they're measuring
1
Change from baseline in Corrected QT intervals (QTc)