A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in
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Full eligibility criteria for NCT01452607
Ages eligible for Study
19 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
Healthy adult male and female subjects
Within 15% of their ideal weights (Table of "Desirable Weights of Adults," Metropolitan Life Insurance Company, 1983)
Medically healthy subjects with clinically insignificant screening results (laboratory profiles, medical histories, ECGs, physical exam);
Voluntarily consented to participate in the study;
Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to screening and throughout the study or used one of the following acceptable birth control methods: Intrauterine device (IUD) in place for at least 3 months prior to study; Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; Stable hormonal contraceptive for at least 3 months prior to study through completion of study; Surgical sterilization (vasectomy) of partner at least 6 months prior to study. Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).
History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease;
History or presence of alcoholism or drug abuse within the past 2 years;
Hypersensitivity or idiosyncratic reaction to compounds related to ebselen;
Use of any prescription medication within 14 days (with the exception of hormonal contraceptives) prior to or during the study;
Use of any over-the-counter medication including vitamins, herbal preparations, antacids, cough and cold remedies, etc., within 7 days prior or during the study;
Use of any drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 28 days prior to dosing;
Abnormal diet (for any reason) during the 30 days prior to dosing;
Donation of whole blood within 56 days prior to the study;
Plasma donation within 7 days prior to the study;
Participation in another clinical trial within 30 days prior to the study;
Female subjects who were pregnant or lactating;
Hemoglobin < 12.0 g/dL;
Orthostatic vital signs which result in: A pulse increase of more than 30 beats per minute after 3 minutes standing (compared with semi-recumbent pulse rate); or A pulse rate greater than 100 bpm after 3 minutes standing; or A drop in systolic blood pressure decrease of at least 20 mm Hg; or A diastolic blood pressure decrease of at least 10 mm Hg within 3 minutes of standing (compared with semi-recumbent blood pressure).
All locations for NCT01452607
United States (1)
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
View full eligibility
Tris trial is registered with FDA with number: NCT01452607. The sponsor of the trial is Sound Pharmaceuticals, Incorporated and it is looking for 32 volunteers for the current phase.
Official trial title: A Phase 1, Double-blind, Placebo-controled, Randomized Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SPI-1005 (Ebselen)in Healthy Adult Subjects
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