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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01411800
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : July 20, 2012
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

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 Type : Interventional  (Clinical Trial)
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 : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : May 2012

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

Primary Outcome Measures :
  1. Urinary 5-HIAA levels [ Time Frame: 34 days ]
  2. Plasma 5-HIAA levels [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration [ Time Frame: 32 days ]
  2. Time at which maximum observed plasma concentration occurs [ Time Frame: 32 days ]
  3. Half-life of the drug in plasma [ Time Frame: 32 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01411800

United States, Kansas
Lexicon Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Lexicon Pharmaceuticals
Study Director: Ikenna Ogbaa, MD Lexicon Pharmaceuticals, Inc.

Responsible Party: Lexicon Pharmaceuticals Identifier: NCT01411800     History of Changes
Other Study ID Numbers: LX1033.1-103-NRM
LX1033.103 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases