Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-02-29

Brief Summary

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The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.

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Detailed Description

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This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ST-246

250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days

Group Type EXPERIMENTAL

ST-246

Intervention Type DRUG

250 mg, 400 mg or 800 mg capsules given once daily for 21 days

placebo

Placebo to match ST-246

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules to match experimental drug

Interventions

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ST-246

250 mg, 400 mg or 800 mg capsules given once daily for 21 days

Intervention Type DRUG

Placebo

Capsules to match experimental drug

Intervention Type DRUG

Other Intervention Names

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Tecovirimat Placebo to match ST-246

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Ability to Consent
* Not taking any other medication
* Adequate venous access
* Using adequate birth control

Exclusion Criteria

* Inability to swallow study medication.
* Pregnant or breastfeeding
* Received experimental drug within 30 days of study entry or will participate in any experimental study during the study period.
* Current drug abuse, alcohol abuse, or homelessness.
* Taking concomitant medication
* Lactose Intolerance
* Medical condition; e.g., asthma, diabetes, thyroid disease, angioedema, BMI \>35 or \<18, hypertension, bleeding disorder, malignancy, seizure, neutropenia, Hepatitis B or C, HIV or AIDS.
* Any condition, occupational reason or other responsibility that, in the judgment of the Investigator, would jeopardize the safety or rights of a volunteer, or render the subject unable to comply with the protocol

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes