Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

NCT ID: NCT01452607

Last Updated: 2016-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2006-08-31

Brief Summary

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

Conditions

Hearing Loss; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SPI-1005 Capsule 200mg Ebselen x1

Lowest Dose Evaluated, 200mg Ebselen Total, Delivered as a Single Dose

Group Type: EXPERIMENTAL

SPI-1005

Intervention Type: DRUG

200 mg Ebselen oral capsules (SPI-1005), single dose

SPI-1005 Capsule 200mg Ebselen x2

2x Lowest Dose Evaluated, 400mg Ebselen Total, Delivered as a Single Dose

Group Type: EXPERIMENTAL

SPI-1005

Intervention Type: DRUG

200 mg Ebselen oral capsules (SPI-1005), single dose

SPI-1005 Capsule 200mg Ebselen x4

4x Lowest Dose Evaluated, 800mg Ebselen Total, Delivered as a Single Dose

Group Type: EXPERIMENTAL

SPI-1005

Intervention Type: DRUG

200 mg Ebselen oral capsules (SPI-1005), single dose

SPI-1005 Capsule 200mg Ebselen x8

8x Lowest Dose Evaluated, 1600mg Ebselen Total, Delivered as a Single Dose

Group Type: EXPERIMENTAL

SPI-1005

Intervention Type: DRUG

200 mg Ebselen oral capsules (SPI-1005), single dose

SPI-1000 Capsule 0 mg Ebselen Placebo

Matching Placebo Capsule, 0mg Ebselen Total, Delivered as a Single Dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0 mg Ebselen oral capsules (SPI-1000), single dose

Interventions

SPI-1005

200 mg Ebselen oral capsules (SPI-1005), single dose

Intervention Type: DRUG

Placebo

0 mg Ebselen oral capsules (SPI-1000), single dose

Intervention Type: DRUG

Other Intervention Names

200 mg Ebselen; 0 mg Ebselen

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).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sound Pharmaceuticals, Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James C. Kisicki, M.D.

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

MDS Pharma Services

Lincoln, Nebraska, United States

Countries

United States

References

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

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 32483557 (View on PubMed)

Other Identifiers

SPI-1005-101

Identifier Type: -

Identifier Source: org_study_id