An Open-Label Study of Two Formulations of LX1033 in Heal... | NCT01411800

Studies
An Open-Label Study of Two Formulations of LX1033 in Healthy Human Subjects

NCT01411800

Sponsor

Lexicon Pharmaceuticals

Status

Completed

Last Update Posted

Jul 20, 2012Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Irritable Bowel Syndrome

Interventions

250 mg capsule
250 mg tablets

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

ID	Type	Description	Link
LX1033.103	Other Identifier	Lexicon Pharmaceuticals, Inc.

Status Module

Record Verification Date

Jul 2012

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

Aug 2011

Primary Completion Date

Oct 2011Actual

Completion Date

May 2012Actual

First Submitted Date

Aug 5, 2011

First Submission Date that Met QC Criteria

Aug 5, 2011

First Posted Date

Aug 8, 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

Jul 19, 2012

Last Update Posted Date

Jul 20, 2012Estimated

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 purpose of this study is to assess the pharmacodynamic effects, pharmacokinetics, and safety of two oral formulations (tablet and capsule) of LX1033 in normal healthy 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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Experimental	500 mg LX1033, capsules administered two times per day orally	Drug: 250 mg capsule
Treatment B	Experimental	500 mg LX1033, tablets administered two times per day orally	Drug: 250 mg tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
250 mg capsule	Drug	Two 250 mg capsules will be administered for 500 mg dose	Treatment A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary 5-HIAA levels		34 days
Plasma 5-HIAA levels		30 days

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed plasma concentration		32 days
Time at which maximum observed plasma concentration occurs		32 days
Half-life of the drug in plasma

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult subjects age 18 to 55 years
Vital signs acceptable at Screening
Body mass index (BMI) between 18 and 35 kg/m^2 at Screening
Considered to be in good health, as determined by the Investigator
Normal ECG findings
Negative urine screen for drugs of abuse and negative breath test for alcohol
Negative hepatitis B surface antigen, hepatitis C antibody, and HIV1 and HIV2 antibody tests within the last 28 days
Ability to provide written informed consent

Exclusion Criteria:

Use of any medication (including acetaminophen) within 5 days of dosing
Use of any investigational agent or selective serotonin reuptake inhibitors (SSRIs) within 30 days of study start
Administration of any protein or antibodies within 90 days of study start
Donation or loss of greater than 450 mL of blood within 45 days of study start
Known history of hepatic disease or significantly abnormal liver function tests
History of alcoholism or substance abuse within 3 years prior to study start
Participation in any other clinical study within 30 days preceding the first dose of study drug
Positive serum pregnancy test

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ikenna Ogbaa, MD	Lexicon Pharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Lexicon Investigational Site		Overland Park	Kansas	66211	United States

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided