Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

Sound Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hearing Loss; Cancer

Treatments: Drug: Placebo; Drug: SPI-1005

Study type: Interventional

Funder types: Industry

Identifiers

NCT01452607

SPI-1005-101

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 5 patient groups, including a placebo group

SPI-1005 Capsule 200mg Ebselen x1

Experimental group

Description:

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

Treatment:

Drug: SPI-1005

SPI-1005 Capsule 200mg Ebselen x2

Experimental group

Description:

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

Treatment:

Drug: SPI-1005

SPI-1005 Capsule 200mg Ebselen x4

Experimental group

Description:

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

Treatment:

Drug: SPI-1005

SPI-1005 Capsule 200mg Ebselen x8

Experimental group

Description:

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

Treatment:

Drug: SPI-1005

SPI-1000 Capsule 0 mg Ebselen Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo