Study to Investigate the Interaction Between FG-4592 and... | NCT01376063

Studies
Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

NCT01376063

Sponsor

Kyntra Bio

Status

Completed

Last Update Posted

Jun 20, 2011Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy Adult Subjects

Interventions

FG-4592

Countries

Not provided

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 2011

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

Mar 2010

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 16, 2011

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 20, 2011Estimated

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 17, 2011

Last Update Posted Date

Jun 20, 2011Estimated

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 primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the plasma pharmacokinetic of rosiglitazone in 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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FG-4592	Experimental		Drug: FG-4592

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FG-4592	Drug	FG-4592 on days 3,5,7,9 Rosiglitazone maleate on days 1 and 9	FG-4592

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in plasma concentration of Rosiglitazone		Day 1- Day 11

Secondary Outcomes

Measure	Description	Time Frame
Change in plasma concentration of Rosiglitazone metabolites		Day 3 - Day 11

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult males, 18 to 45 years
Body weight ≥ 75 kg
Good health
Non-smoker
Blood pressure not greater than 140/90 mm Hg

Exclusion Criteria:

Positive for any of the following: Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
Blood donation or significant blood loss within 60 days prior to Day 1
Use of prescription and over the counter medications/herbal preparations is not allowed within 14 days prior to Day 1 and through treatment phase
History or presence of alcoholism or drug abuse within 2 years prior to Day 1
Consumption of alcohol within 7 days prior to Day 1 or during treatment phase
Positive urine drug/alcohol testing at screening or check-in visit

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

Intervention Browse Module

MeSH Terms

ID	Term
C584543	roxadustat

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided