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

NCT01411800 | Completed Phase 1

• 2 other identifiers: LX1033.1-103-NRMLX1033.103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Urinary 5-HIAA levels

  34 days

• Plasma 5-HIAA levels

  30 days

Secondary Outcomes (3)

• Maximum observed plasma concentration

  32 days

• Time at which maximum observed plasma concentration occurs

  32 days

• Half-life of the drug in plasma

  32 days

Study Arms (2)

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

250 mg capsule DRUG

Two 250 mg capsules will be administered for 500 mg dose

Treatment A

250 mg tablets DRUG

Two 250 mg tablets will be administered for a 500 mg dose

Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (1)

Lexicon Investigational Site

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ikenna Ogbaa, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2012
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

US (1)