Cancer, Hearing Loss
Conditions
Keywords
Ebselen
Brief summary
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
Interventions
DRUGSPI-1005
200 mg Ebselen oral capsules (SPI-1005), single dose
DRUGPlacebo
0 mg Ebselen oral capsules (SPI-1000), single dose
Sponsors
Sound Pharmaceuticals, Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed