Safety and Efficacy Study of DAV132 in Healthy Volunteers

NCT02176005 | Completed Phase 1 Results

• 2 other identifiers: DAV132-CL-1002ID-RCB number 2013-A01504-41
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)

  D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16

Secondary Outcomes (7)

• Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37)

  D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37

• Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1

  D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose

• Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5

  D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose

• Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1

  D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose

• Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5

  D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose

Study Arms (4)

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin, oral tablets, 400mg/day, once daily 5 days

Drug: Moxifloxacin

moxifloxacin + DAV132

EXPERIMENTAL

Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days

Device: DAV132; Drug: Moxifloxacin

DAV132

EXPERIMENTAL

DAV132 oral, 7.5g x3/day for 7 days

Device: DAV132

Negative control

PLACEBO COMPARATOR

Negative control: 7.5g x3/day for 7 days

Other: Negative Control

Interventions

DAV132 DEVICE

DAV132 is associated to moxifloxacin or it is evaluated alone

DAV132; moxifloxacin + DAV132

Moxifloxacin DRUG

Moxifloxacin is used alone or associated to DAV132

Also known as: Avelox

Moxifloxacin; moxifloxacin + DAV132

Negative Control OTHER

Moxifloxacin is used alone

Negative control

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers
• Normal digestive transit, with usually one daily stool.
• Females participating in the study :
• Having given and signed the written study informed consent prior to undertaking any study-related procedure.
• Covered by the French Health Insurance system.

You may not qualify if:

• 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.
• Any vaccination within the last 28 days.

Sponsors & Collaborators

• Da Volterra: lead

Study Sites (1)

CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard

Paris, 75O18, France

Location

Related Publications (3)

• Edlund C, Beyer G, Hiemer-Bau M, Ziege S, Lode H, Nord CE. Comparative effects of moxifloxacin and clarithromycin on the normal intestinal microflora. Scand J Infect Dis. 2000;32(1):81-5. doi: 10.1080/00365540050164272.

  PMID: 10716083 BACKGROUND

• Burkhardt O, Borner K, Stass H, Beyer G, Allewelt M, Nord CE, Lode H. Single- and multiple-dose pharmacokinetics of oral moxifloxacin and clarithromycin, and concentrations in serum, saliva and faeces. Scand J Infect Dis. 2002;34(12):898-903. doi: 10.1080/0036554021000026963.

  PMID: 12587622 BACKGROUND

• de Gunzburg J, Ghozlane A, Ducher A, Le Chatelier E, Duval X, Ruppe E, Armand-Lefevre L, Sablier-Gallis F, Burdet C, Alavoine L, Chachaty E, Augustin V, Varastet M, Levenez F, Kennedy S, Pons N, Mentre F, Andremont A. Protection of the Human Gut Microbiome From Antibiotics. J Infect Dis. 2018 Jan 30;217(4):628-636. doi: 10.1093/infdis/jix604.

  PMID: 29186529 DERIVED

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Annie Ducher, Chief Medical Officer
• Organization: Da Volterra

annie.ducher@davolterra.com

+33 1 58 39 32 20

Study Officials

• Xavier Duval, MD

  CIC Bichat, Paris France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: June 25, 2014
• First Posted: June 26, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02

Locations

FR (1)