Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Subjects

In brief

The purpose of this study is to determine the safety and pharmacokinetics following a single oral dose of MBX-400.

Key facts

Study ID

NCT01433835

Run by

Microbiotix, Inc.

People needed

48

Starts

2011-09-01

Expected to finish

2012-09-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female 18 to 65 years of age
• Females must be surgically-sterilized or post-menopausal (defined as at least 1 year since last menses with follicle stimulating hormone (FSH) level indicating subject is post-menopausal)
• Males must have undergone vasectomy
• Able to understand study requirements, agrees to participate in the study and willing and able to provide informed consent (using an informed consent form in a language in which the subject is fluent)
• Willing and able to stay in a clinical facility for up to 7 days
• BMI of 18 to 32 kg/m2
• Non-smoker or former smoker or user of nicotine-containing products (defined as someone who smoked or used nicotine-products one or more times a week for at least one month) who has not smoked for at least 3 months and has not used nicotine-containing products for at least 1 month and is willing to abstain from nicotine-containing products during the study
• Has adequate venous access
• Willing to abstain from alcohol and illicit drugs during the study

You may not qualify if…

• Participation in another clinical trial within 3 months of screening
• Unwilling to comply with study procedures or cooperate with study personnel.
• Donated blood or had significant blood loss (greater than 1 unit) within 3 months of screening
• History of any of the following
• Human immunodeficiency virus (HIV), cytomegalovirus (CMV), hepatitis B or hepatitis C infection
• Alcohol or drug abuse
• Anemia or bleeding disorders
• Gastrointestinal disorders
• Chronic illness
• Regular medication use (prescription, over-the-counter or herbal; defined as more than once per week; except multivitamins) or use of medication (except multivitamins) within 1 week of screening.
• Recent illness requiring treatment within 1 month of screening
• History of renal failure or renal insufficiency
• Clinically significant abnormal electrocardiogram (e.g., abnormal rhythm, abnormal intervals)
• Clinically significant results of hematology, chemistry, coagulation studies or urinalysis, including, but not limited to the following:
• White blood cell count, red blood cell count or platelet count less than the lower limit of normal or greater than 1.5 times the upper limit of normal
• Hemoglobin or hematocrit less than the lower limit of normal or greater than the upper limit of normal
• Alanine aminotransferase and aspartate aminotransferase greater than the upper limit of normal
• Prothrombin, partial thromboplastin time or international normalized ratio greater than 1.5 times the upper limit of normal
• Abnormal electrolyte values (i.e., sodium, potassium, carbon dioxide/bicarbonate, chloride and/or calcium outside of the reference range)
• Urinalysis showing presence of red blood cells, protein or microalbumin
• Cotinine level indicative of nicotine use
• Positive test for any drug of abuse on urine drug screen
• Positive serum pregnancy test if female
• Positive ethanol test
• Clinically significant vital signs

Where it is running

• Frontage Clinical Research Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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