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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01411800
First received: August 5, 2011
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
 Drug: 250 mg capsule
Drug: 250 mg tablets
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Urinary 5-HIAA levels [ Time Frame: 34 days ] [ Designated as safety issue: No ]
  • Plasma 5-HIAA levels [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed plasma concentration [ Time Frame: 32 days ] [ Designated as safety issue: No ]
  • Time at which maximum observed plasma concentration occurs [ Time Frame: 32 days ] [ Designated as safety issue: No ]
  • Half-life of the drug in plasma [ Time Frame: 32 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 2011
Study Completion Date: May 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411800

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

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01411800     History of Changes
Other Study ID Numbers: LX1033.1-103-NRM, LX1033.103
Study First Received: August 5, 2011
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013