Single-Dose Safety Study of APD791 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Brief Summary

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The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy adult volunteers

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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APD791

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult men and women, ages 19-45
* Non smokers

Exclusion Criteria

* History of a bleeding disorder
* Recently donated blood or had significant blood loss
* Current use of a prescription medication
* Pregnant females

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Arena Pharmaceuticals, Inc.

Principal Investigators

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Christen Anderson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Arena Pharmaceuticals

Locations

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MDS Pharma Services

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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APD791-001

Identifier Type: -

Identifier Source: org_study_id