Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
- Registration Number
- NCT01452607
- Lead Sponsor
- Sound Pharmaceuticals, Incorporated
- Brief Summary
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPI-1005 Capsule 200mg Ebselen x8 SPI-1005 8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose SPI-1005 Capsule 200mg Ebselen x1 SPI-1005 Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose SPI-1005 Capsule 200mg Ebselen x4 SPI-1005 4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose SPI-1000 Capsule 0 mg Ebselen Placebo Placebo Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose SPI-1005 Capsule 200mg Ebselen x2 SPI-1005 2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability 1 month The primary objective of this study was to evaluate the safety and tolerability of SPI-1005 (ebselen) in healthy subjects. Incidence and severity of Adverse Events were determined in all treatment and placebo groups.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects 24 hours Evaluate the single dose pharmacokinetic profile of SPI-1005 in healthy subjects including Tmax, Cmax, of the parent compound and major metabolites.
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Lincoln, Nebraska, United States