Status:
COMPLETED
Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers
Lead Sponsor:
Microbiotix, Inc.
Conditions:
Healthy Adult Subjects
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and pharmacokinetics following a single oral dose of MBX-400.
Detailed Description
Cytomegalovirus (CMV; herpesvirus 5), a member of the betaherpesvirus subgroup, occurs as a benign infection in the majority of humans, with a 90% prevalence in the adult population1. However, CMV inf...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Temperature above 100.0 °F
- Heart rate \< 45 or \> 100 beats per minute
- Respiratory rate \< 12 or \> 20 breaths per minute
- Systolic blood pressure \< 100 or \> 140 mm Hg OR diastolic blood pressure \< 60 or \> 90 mm Hg
- Known hypersensitivity to any ingredients in the MBX-400 capsules or Placebo capsules (e.g., MBX-400, microcrystalline cellulose, gelatin, titanium dioxide).
- Scheduled for surgical procedure during the study
- Investigator deems that subject has a condition that warrants exclusion from or is not suitable for the study
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01433835
Start Date
September 1 2011
End Date
September 1 2012
Last Update
August 2 2013
Active Locations (1)
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1
Frontage Clinical Research Center
Hackensack, New Jersey, United States, 07601