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OpenTrials
Completed

NCT Number: NCT01411800

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

250 mg capsule

Drug

Two 250 mg capsules will be administered for 500 mg dose

250 mg tablets

Drug

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

Primary outcomes

  1. Urinary 5-HIAA levels

    Time frame: 34 days

  2. Plasma 5-HIAA levels

    Time frame: 30 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 8, 2011
Registry last updated
Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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