- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452607
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
June 27, 2016 updated by: Sound Pharmaceuticals, Incorporated
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- MDS Pharma Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SPI-1005 Capsule 200mg Ebselen x1
Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose
|
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Names:
|
Experimental: SPI-1005 Capsule 200mg Ebselen x2
2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose
|
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Names:
|
Experimental: SPI-1005 Capsule 200mg Ebselen x4
4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose
|
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Names:
|
Experimental: SPI-1005 Capsule 200mg Ebselen x8
8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose
|
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Names:
|
Placebo Comparator: SPI-1000 Capsule 0 mg Ebselen Placebo
Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose
|
0 mg Ebselen oral capsules (SPI-1000), single dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 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.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects
Time Frame: 24 hours
|
Evaluate the single dose pharmacokinetic profile of SPI-1005 in healthy subjects including Tmax, Cmax, of the parent compound and major metabolites.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James C. Kisicki, M.D., MDS Pharma Services
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garland M, Hryckowian AJ, Tholen M, Bender KO, Van Treuren WW, Loscher S, Sonnenburg JL, Bogyo M. The Clinical Drug Ebselen Attenuates Inflammation and Promotes Microbiome Recovery in Mice after Antibiotic Treatment for CDI. Cell Rep Med. 2020 Apr 21;1(1):100005. doi: 10.1016/j.xcrm.2020.100005.
- Lynch E, Kil J. Development of Ebselen, a Glutathione Peroxidase Mimic, for the Prevention and Treatment of Noise-Induced Hearing Loss. Semin Hear 2009; 30(1): 047-055
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
October 10, 2011
First Submitted That Met QC Criteria
October 14, 2011
First Posted (Estimate)
October 17, 2011
Study Record Updates
Last Update Posted (Estimate)
June 29, 2016
Last Update Submitted That Met QC Criteria
June 27, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Ear Diseases
- Sensation Disorders
- Hearing Disorders
- Hearing Loss
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gastrointestinal Agents
- Neuroprotective Agents
- Protective Agents
- Anti-Ulcer Agents
- Antioxidants
- Ebselen
Other Study ID Numbers
- SPI-1005-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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