Status:
COMPLETED
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
Lead Sponsor:
Sound Pharmaceuticals, Incorporated
Conditions:
Hearing Loss
Cancer
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01452607
Start Date
May 1 2006
End Date
August 1 2006
Last Update
June 29 2016
Active Locations (1)
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1
MDS Pharma Services
Lincoln, Nebraska, United States, 68502