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Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01452607
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Brief Summary:
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.

Condition or disease Intervention/treatment Phase
Hearing Loss Cancer Drug: SPI-1005 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: SPI-1005 Capsule 200mg Ebselen x1
Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose
Drug: SPI-1005
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Name: 200 mg Ebselen

Experimental: SPI-1005 Capsule 200mg Ebselen x2
2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose
Drug: SPI-1005
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Name: 200 mg Ebselen

Experimental: SPI-1005 Capsule 200mg Ebselen x4
4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose
Drug: SPI-1005
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Name: 200 mg Ebselen

Experimental: SPI-1005 Capsule 200mg Ebselen x8
8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose
Drug: SPI-1005
200 mg Ebselen oral capsules (SPI-1005), single dose
Other Name: 200 mg Ebselen

Placebo Comparator: SPI-1000 Capsule 0 mg Ebselen Placebo
Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose
Drug: Placebo
0 mg Ebselen oral capsules (SPI-1000), single dose
Other Name: 0 mg Ebselen




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452607


Locations
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United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
Investigators
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Principal Investigator: James C. Kisicki, M.D. MDS Pharma Services
Publications of Results:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT01452607    
Other Study ID Numbers: SPI-1005-101
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sound Pharmaceuticals, Incorporated:
Ebselen
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Ebselen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents