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

• Sponsor: Lexicon Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01411800
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Drug: 250 mg capsule; Drug: 250 mg tablets	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Open-Label, Two-Way Crossover Study of Two Oral Formulations of LX1033 in Healthy Human Subjects
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A 500 mg LX1033, capsules administered two times per day orally	Drug: 250 mg capsule; Two 250 mg capsules will be administered for 500 mg dose
Experimental: Treatment B 500 mg LX1033, tablets administered two times per day orally	Drug: 250 mg tablets; Two 250 mg tablets will be administered for a 500 mg dose

Outcome Measures

Primary Outcome Measures

1. Urinary 5-HIAA levels [34 days]

2. Plasma 5-HIAA levels [30 days]

Secondary Outcome Measures

1. Maximum observed plasma concentration [32 days]

2. Time at which maximum observed plasma concentration occurs [32 days]

3. Half-life of the drug in plasma [32 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lexicon Investigational Site	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

• Lexicon Pharmaceuticals

Investigators

• Study Director: Ikenna Ogbaa, MD, Lexicon Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lexicon Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01411800
• Other Study ID Numbers: LX1033.1-103-NRM; LX1033.103
• First Posted: Aug 8, 2011
• Last Update Posted: Jul 20, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Irritable Bowel Syndrome

Study Results

No Results Posted as of Jul 20, 2012