Safety and Efficacy Study of Different DAV132 Dose Regimens in Healthy Volunteers

NCT02917200 | Completed Phase 1

• 2 other identifiers: DAV132-CL-10042015-A01899-40
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Area under the curve of free moxifloxacin fecal concentrations from D1 to D16 (AUC D1-D16)

  over 16 days after treatment start

Secondary Outcomes (6)

• Bacterial diversity of the intestinal microbiota (16S rDNA profiling)

  over 37 days after treatment start

• Area under the curve of moxifloxacin plasma concentrations from 0 to 24 hours (AUC0-24h) on D1 and D5

  over 5 days after treatment start

• Maximum moxifloxacin plasma concentrations (Cmax) on D1 and D5

  over 5 days after treatment start

• Number of adverse events and percentage of subjects with at least one adverse event

  over 37 days after treatment start

• Number of subjects with samples positive for treatment-emergent quinolone / fluoroquinolone-resistant Enterobacteriaceae

  over 37 days after treatment start

Study Arms (12)

MOX + CTRL

ACTIVE COMPARATOR

Moxifloxacin, 400 mg/day oad, 5 days + Negative control, tid, 7 days

Drug: Moxifloxacin; Other: Negative control

MOX + DAV132 7.5 g tid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g tid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 7.5 g bid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g bid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 5 g tid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g tid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 5 g bid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g bid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 3.3 g tid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3.3 g tid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 3 g bid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3 g bid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 2 g tid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 2 g tid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 1.5 g bid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1.5 g bid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 1 g tid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g tid, 7 days

Drug: Moxifloxacin; Device: DAV132

MOX + DAV132 1 g bid

EXPERIMENTAL

Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g bid, 7 days

Drug: Moxifloxacin; Device: DAV132

CTRL

OTHER

Negative control, tid, 7 days

Other: Negative control

Interventions

Moxifloxacin DRUG

Oral route

MOX + CTRL; MOX + DAV132 1 g bid; MOX + DAV132 1 g tid; MOX + DAV132 1.5 g bid; MOX + DAV132 2 g tid; MOX + DAV132 3 g bid; MOX + DAV132 3.3 g tid; MOX + DAV132 5 g bid; MOX + DAV132 5 g tid; MOX + DAV132 7.5 g bid; MOX + DAV132 7.5 g tid

DAV132 DEVICE

Oral route

MOX + DAV132 1 g bid; MOX + DAV132 1 g tid; MOX + DAV132 1.5 g bid; MOX + DAV132 2 g tid; MOX + DAV132 3 g bid; MOX + DAV132 3.3 g tid; MOX + DAV132 5 g bid; MOX + DAV132 5 g tid; MOX + DAV132 7.5 g bid; MOX + DAV132 7.5 g tid

Negative control OTHER

Oral route

CTRL; MOX + CTRL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults (males and females), able to read and write, aged from 18 to 60 years old inclusive.
• Body mass index (BMI) 18.5 - 30 kg/m² inclusive.
• Considered as healthy individuals according to a comprehensive clinical assessment (detailed medical history and full physical examination).
• Normal vital signs after 10-min rest in supine position: systolic blood pressure 95 - 140 mmHg inclusive, diastolic blood pressure 45 - 90 mmHg inclusive and heart rate (pulse rate) 50 - 100 bpm inclusive. Out of range values can be accepted if judged clinically non relevant by the Investigator.
• Normal 12-lead ECG after 10-min rest in supine position: PR interval 120 - 220 msec exclusive, QRS complex \<120 msec, and QT interval \<430 msec if male or \<450 msec if female.
• Normal hematology and blood biochemistry test results. Out of range values can be accepted if judged clinically non relevant by the Investigator excepted for potassium and magnesium for which normal values are required.
• Normal digestive transit, with at least one daily stool.
• Females participating in the study:
• or must have a negative pregnancy test and be not breastfeeding at screening, and must use abstinence or a double contraception method during the treatment period and for an additional period of 2 weeks after the end of investigational treatment. The accepted double contraception methods include the use of a highly effective method of birth control (intrauterine device or hormonal contraception) in addition to one of the following contraceptive options: (1) condom, (2) diaphragm or cervical/vault cap, (3) spermicide.
• Having given and signed the written study informed consent prior to undertake any study-related procedure.
• Covered by the French health insurance system.

You may not qualify if:

• Criteria related to the healthy status
• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease; or signs of acute illness.
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for each event, more than twice a month). Subject suffering from migraine on D1 will be excluded.
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
• Criteria specific to the study
• Fecal colonization by C. difficile.
• Recent history of hospitalization (within the last 3 months).
• Any antibiotic administration within the last 3 months.
• Any vaccination within the last 28 days.
• Any previous administration of medication and any previous intake of herbal products known to interfere with drug metabolism such as St John's Wort within the last 14 days, with the exception of hormonal contraception or menopausal hormone replacement therapy or paracetamol.
• Criteria associated with addiction
• History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).
• Smoking more than 5 cigarettes or equivalent per day (including nicotine-delivering devices such as patches, gums and electronic cigarettes), unable to stop smoking during the study.
• Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
• Positive result on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).

Sponsors & Collaborators

• Da Volterra: lead

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yves Donazzolo

  Eurofins Optimed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 28, 2016
• Study Start: May 11, 2016
• Primary Completion: December 2, 2016
• Study Completion: December 2, 2016
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)