HealthyPhase 1NCT02176005

Safety and Efficacy Study of DAV132 in Healthy Volunteers

A Phase 1 study testing DAV132 and Moxifloxacin in people with Healthy, run by Da Volterra at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: DAV132 and Moxifloxacin
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteFrance
Study dates: Mar 2014to Dec 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

France1 site

CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard
Paris, 75O18

Other trials in France

About this study

Official title: Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy Volunteers

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

Read the detailed description

The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:

To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.
To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.

In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.

The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.

Conditions: Healthy
Being tested: DAV132, Moxifloxacin, Negative Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DAV132Device
DAV132 is associated to moxifloxacin or it is evaluated alone
MoxifloxacinDrug
Also called Avelox
Moxifloxacin is used alone or associated to DAV132
Negative ControlOther
Moxifloxacin is used alone

Study groups in NCT02176005
Study group	Role	What they receive
Moxifloxacin	Active comparator	Moxifloxacin, oral tablets, 400mg/day, once daily 5 days Receives: Drug: Moxifloxacin
moxifloxacin + DAV132	Experimental	Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days Receives: Device: DAV132; Drug: Moxifloxacin
DAV132	Experimental	DAV132 oral, 7.5g x3/day for 7 days Receives: Device: DAV132
Negative control	Placebo comparator	Negative control: 7.5g x3/day for 7 days Receives: Other: Negative Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose
Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product
Measured: From randomization to 37 days after the beginning of treatment
Percentage of Subjects With Adverse Events Related to Study Product
Measured: From randomization to 37 days after the beginning of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Dec 2014

First posted26 Jun 2014 (estimated)
Study startMar 2014
Primary completionOct 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02176005
Sponsor's protocol ID: DAV132-CL-1002
Other IDs: ID-RCB number 2013-A01504-41
Status last verified: Feb 2020
First submitted: 25 Jun 2014
Last updated: 28 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 10716083
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.
PubMed 12587622
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.
PubMed 29186529

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy Volunteers
ClinicalTrials.gov ID: NCT02176005
Acronym / sponsor ID: DAV132-CL-1002
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Da VolterraIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Oct 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 26 Jun 2014 (estimated)
Results: Posted 28 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:

To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.
To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.

In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.

The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Moxifloxacin	Active comparator	Drug: MoxifloxacinMoxifloxacin, oral tablets, 400mg/day, once daily 5 days
moxifloxacin + DAV132	Experimental	Device: DAV132, Drug: MoxifloxacinMoxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days
DAV132	Experimental	Device: DAV132DAV132 oral, 7.5g x3/day for 7 days
Negative control	Placebo comparator	Other: Negative ControlNegative control: 7.5g x3/day for 7 days

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DAV132DAV132 is associated to moxifloxacin or it is evaluated alone	Device	DAV132, moxifloxacin + DAV132
MoxifloxacinAlso: AveloxMoxifloxacin is used alone or associated to DAV132	Drug	Moxifloxacin, moxifloxacin + DAV132
Negative ControlMoxifloxacin is used alone	Other	Negative control

Primary outcome

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)
Time frame: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16

7 secondary outcomes

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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose
Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product
Time frame: From randomization to 37 days after the beginning of treatment
Percentage of Subjects With Adverse Events Related to Study Product
Time frame: From randomization to 37 days after the beginning of treatment

Results and safety

Results posted to the registry on 28 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moxifloxacin	14	14
DAV132 + Moxifloxacin	14	14
DAV132	8	8
Negative Control	8	8

Primary outcome: 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)

Time frame: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16. Mean (Standard Deviation). Unit: μg/g.day

Measure	Moxifloxacin n = 14	Moxifloxacin + DAV132 n = 14
Value	758.4 (359.3)	8.28 (7.21)

Moxifloxacin vs Moxifloxacin + DAV132: Contrast (B/A): 0.0093 (95% CI 0.0060 to 0.0144), p <.000001, General linear model

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moxifloxacin	0 of 14 (0%)	6 of 14 (42.9%)	0 of 14
Moxifloxacin + DAV132	0 of 14 (0%)	10 of 14 (71.4%)	0 of 14
DAV132	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Negative Control	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10716083Edlund 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.
Background: PubMed 12587622Burkhardt 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.
Derived from this study: PubMed 29186529de 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xavier Duval, MD principal investigator

CIC Bichat, Paris France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DAV132 and Moxifloxacin in people with Healthy, run by Da Volterra at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02176005, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.