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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


Phase 1
19 Years
50 Years
Not Enrolling
Both
Hearing Loss, Cancer

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

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.

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

James C. Kisicki, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

MDS Pharma Services

Authority:

United States: Food and Drug Administration

Study ID:

SPI-1005-101

NCT ID:

NCT01452607

Start Date:

May 2006

Completion Date:

August 2006

Related Keywords:

  • Hearing Loss
  • Cancer
  • Ebselen
  • Hearing Loss
  • Deafness

Name

Location

MDS Pharma ServicesLincoln, Nebraska  68502