Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
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
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
200 mg Ebselen oral capsules (SPI-1005), single dose
0 mg Ebselen oral capsules (SPI-1000), single dose
Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose
2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose
4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose
8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose
Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose
Inclusion Criteria: 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). Exclusion Criteria: 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).