Study to Evaluate Safety, Pharmacokinetics and Pharmacody... | NCT01203384

Studies
Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

NCT01203384

Sponsor

CERESPIR

Status

Completed

Last Update Posted

Feb 10, 2015Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

CHF5074 1x
CHF5074 2x
CHF5074 3x
Placebo

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

Feb 2015

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

Sep 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 2010Estimated

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

Feb 9, 2015

Last Update Posted Date

Feb 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.

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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHF5074 1x	Experimental	oral tablet, multidose	Drug: CHF5074 1x
CHF5074 2x	Experimental	oral tablet, multidose	Drug: CHF5074 2x
CHF5074 3x	Experimental	oral tablet, multidose	Drug: CHF5074 3x
Placebo	Placebo Comparator	placebo, oral tablet, multidose	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHF5074 1x	Drug	oral tablet, 1x, once a day in the morning for 14 days	CHF5074 1x

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events		from Screening through Day 18

Secondary Outcomes

Measure	Description	Time Frame
Dose linearity of CHF5074 plasma levels (Cmax)		Day -1 through Day 18
Dose linearity of CHF5074 plasma levels (AUC 0-t)		Day -1 through Day 18

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.

Exclusion Criteria:

Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
Significant allergic conditions that require medical treatment
Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Magdy L Shenouda, MD	Iberica Clinical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Iberica Clinical Research Center		Eatontown	New Jersey	07724	United States

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided