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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01411800

Enrollment

Registered

2011-08-08

Start date

2011-08-31

Completion date

2012-05-31

Last updated

2012-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

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.

Interventions

DRUG250 mg capsule

Two 250 mg capsules will be administered for 500 mg dose

DRUG250 mg tablets

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Urinary 5-HIAA levels	34 days
Plasma 5-HIAA levels	30 days

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026