Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Marathon Pharmaceuticals, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Be male or female adults, 18 years of age or older
Have SBS that is inadequately controlled on current antidiarrheal medication (e.g., loperamide or diphenoxylate), including subjects with ileostomies
Must have been deemed a completer of study protocol MP-101-CL-001.
Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months of natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy)
Females of childbearing potential must agree to use 1 of the following acceptable birth control methods:
* Surgically sterile (hysterectomy or bilateral oophorectomy)
* Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)
* Intrauterine device (IUD) in place for at least 3 months
* Abstinence (not having sexual intercourse)
* Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening and through study completion
* Stable hormonal contraceptive for at least 3 months prior to study and through study completion
* Vasectomized partner
Females of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at Visit 1.
Be able to understand and provide signed informed consent
You may not be if
Have any history of or active neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease that is considered clinically significant, is not currently controlled by medication, and is stable as deemed by the Investigator
Are currently taking antibiotics for bacterial overgrowth
Have known or suspected pregnancy, planned pregnancy, or lactation
Have a planned surgery during the course of the study
Have a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk
Clareo Health | A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
