Hearing LossPhase 1NCT01452607
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
A Phase 1 study testing SPI-1005 in people with Hearing Loss and Cancer, run by Sound Pharmaceuticals, Incorporated at 1 site in United States.
Trial summary
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Cancer
- What is being tested?
- SPI-1005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Aug 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
- Conditions
- Hearing Loss, Cancer
- Being tested
- SPI-1005, Placebo
- Keywords
- Ebselen
- Medical subject headings
- Hearing Loss, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-1005Drug
Also called 200 mg Ebselen
200 mg Ebselen oral capsules (SPI-1005), single dose
PlaceboDrug
Also called 0 mg Ebselen
0 mg Ebselen oral capsules (SPI-1000), single dose
| Study group | Role | What they receive |
|---|---|---|
| SPI-1005 Capsule 200mg Ebselen x1 | Experimental | Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose Receives: Drug: SPI-1005 |
| SPI-1005 Capsule 200mg Ebselen x2 | Experimental | 2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose Receives: Drug: SPI-1005 |
| SPI-1005 Capsule 200mg Ebselen x4 | Experimental | 4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose Receives: Drug: SPI-1005 |
| SPI-1005 Capsule 200mg Ebselen x8 | Experimental | 8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose Receives: Drug: SPI-1005 |
| SPI-1000 Capsule 0 mg Ebselen Placebo | Placebo comparator | Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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.
Measured: 1 month
Secondary outcomes (1)
Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects
Evaluate the single dose pharmacokinetic profile of SPI-1005 in healthy subjects including Tmax, Cmax, of the parent compound and major metabolites.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startMay 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James C. Kisicki, M.D., Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452607
- Sponsor's protocol ID
- SPI-1005-101
- Status last verified
- Jun 2016
- First submitted
- 10 Oct 2011
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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
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.
PubMed 32483557
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01452607
- Acronym / sponsor ID
- SPI-1005-101
- Conditions
- Hearing Loss, Cancer
- Keywords
- Ebselen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sound Pharmaceuticals, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SPI-1005 Capsule 200mg Ebselen x1 | Experimental | Drug: SPI-1005Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose |
| SPI-1005 Capsule 200mg Ebselen x2 | Experimental | Drug: SPI-10052x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose |
| SPI-1005 Capsule 200mg Ebselen x4 | Experimental | Drug: SPI-10054x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose |
| SPI-1005 Capsule 200mg Ebselen x8 | Experimental | Drug: SPI-10058x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose |
| SPI-1000 Capsule 0 mg Ebselen Placebo | Placebo comparator | Drug: PlaceboMatching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPI-1005Also: 200 mg Ebselen200 mg Ebselen oral capsules (SPI-1005), single dose | Drug | SPI-1005 Capsule 200mg Ebselen x1, SPI-1005 Capsule 200mg Ebselen x2, SPI-1005 Capsule 200mg Ebselen x4, SPI-1005 Capsule 200mg Ebselen x8 |
| PlaceboAlso: 0 mg Ebselen0 mg Ebselen oral capsules (SPI-1000), single dose | Drug | SPI-1000 Capsule 0 mg Ebselen Placebo |
Primary outcome
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 secondary outcome
Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Results publicationLynch 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
- Derived from this study: PubMed 32483557Garland 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C. Kisicki, M.D. principal investigator
MDS Pharma Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPI-1005 in people with Hearing Loss and Cancer, run by Sound Pharmaceuticals, Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452607, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.