Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452607
• Other study ID #: SPI-1005-101
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2011
• Last updated: June 27, 2016
• Start date: May 2006
• Est. completion date: August 2006

Study information

• Verified date: June 2016
• Source: Sound Pharmaceuticals, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Hearing Loss

Intervention

Drug:
• SPI-1005
200 mg Ebselen oral capsules (SPI-1005), single dose
• Placebo
0 mg Ebselen oral capsules (SPI-1000), single dose

Locations

Country	Name	City	State
United States	MDS Pharma Services	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Sound Pharmaceuticals, Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	24 hours	No