NCT00619931

Brief Summary

The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2008

Typical duration 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

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

February 11, 2008

Last Update Submit

June 29, 2022

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

    Throughout study duration

Secondary Outcomes (2)

  • Pharmacokinetic assessments

    Throughout study duration

  • Pharmacodynamic assessments (e.g., platelet function)

    Throughout study duration

Study Arms (5)

1

EXPERIMENTAL

APD791 or placebo

Drug: APD791

2

EXPERIMENTAL

APD791 or placebo

Drug: APD791

3

EXPERIMENTAL

APD791 or placebo

Drug: APD791

4

EXPERIMENTAL

APD791 or placebo

Drug: APD791

5

EXPERIMENTAL

APD791 or placebo

Drug: APD791

Interventions

APD791DRUG

APD791 or matching placebo in escalating doses

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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
  • Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening
  • 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

  • James Kisicki, MD

    MDS Pharma Services

    PRINCIPAL INVESTIGATOR

  • Christen M Anderson, MD, PhD

    Arena Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 21, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

US(1)