Safety and Efficacy Study of DAV132 in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Da Volterra
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Healthy volunteers

• Normal digestive transit, with usually one daily stool.

• Females participating in the study :

must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.

• Having given and signed the written study informed consent prior to undertaking any study-related procedure.

• Covered by the French Health Insurance system.

Exclusion Criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.

• Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.

• Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.

• Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.

• Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.

• Fecal colonisation by Clostridium difficile.

• Recent history of hospitalisation (within 3 months prior to inclusion).

• Any antibiotic administration within 3 months before inclusion.

• Any vaccination within the last 28 days.