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

Irritable Bowel Syndrome Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411800
• Other study ID #: LX1033.1-103-NRM
• Secondary ID: LX1033.103
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2011
• Last updated: July 19, 2012
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• 250 mg capsule
Two 250 mg capsules will be administered for 500 mg dose
• 250 mg tablets
Two 250 mg tablets will be administered for a 500 mg dose

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary 5-HIAA levels		34 days	No
Primary	Plasma 5-HIAA levels		30 days	No
Secondary	Maximum observed plasma concentration		32 days	No
Secondary	Time at which maximum observed plasma concentration occurs		32 days	No
Secondary	Half-life of the drug in plasma		32 days	No