NCT00529646

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
Last Updated

December 30, 2008

Status Verified

December 1, 2008

First QC Date

September 12, 2007

Last Update Submit

December 29, 2008

Conditions

Healthy

Keywords

Healthy adult volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters

Secondary Outcomes (1)

  • Pharmacokinetic and pharmacodynamic assessments

Interventions

APD791DRUG

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

Location

Related Links

MeSH Terms

Interventions

APD791

Study Officials

  • Christen Anderson, MD, PhD

    Arena Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

July 1, 2007

Last Updated

December 30, 2008

Record last verified: 2008-12

Locations

US(1)