Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

NCT01452607 | Completed Phase 1 DMC

• 1 other identifier: SPI-1005-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hearing Loss; Cancer

Keywords

Ebselen

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (1)

• Pharmacokinetics of SPI-1005 and its major metabolites in healthy subjects

  24 hours

Study Arms (5)

SPI-1005 Capsule 200mg Ebselen x1

EXPERIMENTAL

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

Drug: SPI-1005

SPI-1005 Capsule 200mg Ebselen x2

EXPERIMENTAL

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

Drug: SPI-1005

SPI-1005 Capsule 200mg Ebselen x4

EXPERIMENTAL

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

Drug: SPI-1005

SPI-1005 Capsule 200mg Ebselen x8

EXPERIMENTAL

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

Drug: SPI-1005

SPI-1000 Capsule 0 mg Ebselen Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SPI-1005 DRUG

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

Also known as: 200 mg Ebselen

SPI-1005 Capsule 200mg Ebselen x1; SPI-1005 Capsule 200mg Ebselen x2; SPI-1005 Capsule 200mg Ebselen x4; SPI-1005 Capsule 200mg Ebselen x8

Placebo DRUG

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

Also known as: 0 mg Ebselen

SPI-1000 Capsule 0 mg Ebselen Placebo

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sound Pharmaceuticals, Incorporated: lead

Study Sites (1)

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

Location

Related Publications (2)

• 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

  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.

  PMID: 32483557 DERIVED

MeSH Terms

Conditions

Hearing Loss; Neoplasms

Interventions

ebselen

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James C. Kisicki, M.D.

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 17, 2011
• Study Start: May 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

US (1)