Clinical trial NCT01452607: Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hearing Loss
Cancer
Keywords: Ebselen
Lead sponsor: Sound Pharmaceuticals, Incorporated
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1 month
Secondary outcomes:
measure: Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services
state: Nebraska
Study officials:
affiliation: MDS Pharma Services
name: James C. Kisicki, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.