A Multiple-Dose Study to Assess the Safety, Tolerability,... | NCT00619931

Studies
A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers

NCT00619931

Sponsor

Arena Pharmaceuticals

Status

Completed

Last Update Posted

Jul 5, 2022Actual

Enrollment

50Actual

Phase

Phase 1

Conditions

Healthy

Interventions

APD791

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Feb 11, 2008

First Submission Date that Met QC Criteria

Feb 11, 2008

First Posted Date

Feb 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2022

Last Update Posted Date

Jul 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
APD791	Drug	APD791 or matching placebo in escalating doses	1 2 3 4 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters		Throughout study duration

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic assessments		Throughout study duration
Pharmacodynamic assessments (e.g., platelet function)		Throughout study duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Kisicki, MD	MDS Pharma Services	Principal Investigator
Christen M Anderson, MD, PhD	Arena Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MDS Pharma Services		Lincoln	Nebraska	68502	United States

Label	URL
Arena Home Page	View source

Intervention Browse Module

MeSH Terms

ID	Term
C544126	APD791

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided